Safety and Efficacy of the SurVeil™ Drug-Coated Balloon

Peripheral Arterial Disease Clinical Trial

— TRANSCEND  

Official title:

Randomized & Controlled Noninferiority Trial to Evaluate Safety & Clinical Efficacy of SurVeil™ Drug-Coated Balloon (DCB) iN Treatment of Subjects With Stenotic Lesions of Femoropopliteal Artery Compared to Medtronic IN.PACT® Admiral® DCB

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03241459
• Other study ID #: SUR17-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 23, 2017
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• Source: SurModics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral and/or popliteal arteries.

Description:

TRANSCEND is a prospective, multi-center, single-blind, randomized, controlled, noninferiority clinical trial. The trial will randomize approximately 446 subjects with symptomatic PAD due to stenoses of the femoral and/or popliteal arteries. Subjects meeting eligibility criteria will be randomized 1:1 to treatment with either the SurVeil DCB or the IN.PACT Admiral DCB, and followed for 60 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 446
• Est. completion date: October 2024
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is =18 years.

• Subject has target limb Rutherford classification 2, 3 or 4.

• Subject has provided written informed consent and is willing to comply with study follow-up requirements.

• De novo lesion(s) or non-stented restenotic lesion(s) occurring >90 days after prior plain old balloon (POBA) angioplasty or >180 days after prior DCB treatment.

• Target lesion location starts =10 mm below the common femoral bifurcation and terminates distally at or above the end of the P1 segment of the popliteal artery.

• Target vessel diameter =4 mm and =7 mm.

• Target lesion must have angiographic evidence of =70% stenosis by operator visual estimate.

• Chronic total occlusions may be included only after successful, uncomplicated wire crossing of target lesion via an anterograde approach and without the use of subintimal dissection techniques.

• Target lesion must be =180 mm in length (one long lesion or multiple serial lesions) by operator visual estimate. Note: combination lesions must have a total lesion length of =180 mm by visual estimate and be separated by =30 mm.

• Target lesion is located at least 30 mm from any stent, if target vessel was previously stented.

• Successful, uncomplicated (without use of a crossing device) wire crossing of target lesion. Successful crossing of the target lesion occurs when the tip of the guide wire is distal to the target lesion without the occurrence of flow-limiting dissection or perforation and is judged by visual inspection to be within the true lumen.

• After pre-dilatation, the target lesion is =70% residual stenosis, absence of a flow limiting dissection and treatable with available device matrix.

• A patent inflow artery free from significant stenosis (=50% stenosis) as confirmed by angiography.

• At least one patent native outflow artery to the ankle or foot, free from significant stenosis (=50% stenosis) as confirmed by angiography.

Exclusion Criteria:

• Subject has acute limb ischemia.

• Subject underwent percutaneous transluminal angioplasty (PTA) of the target limb using plain old balloon angioplasty (POBA) or a stent within the previous 90 days.

• Subject underwent any lower extremity percutaneous treatment using a paclitaxel-eluting stent or a DCB within the previous 90 days.

• Subject underwent PTA of the target lesion using a DCB within the previous 180 days.

• Subject has had prior vascular intervention in the contralateral limb within 14 days before the planned study index procedure or subject has planned vascular intervention in the contralateral limb within 30 days after the index procedure.

• Subject is pregnant, breast-feeding or intends to become pregnant during the time of the study.

• Subject has life expectancy less than 2 years.

• Subject has a known allergy to contrast medium that cannot be adequately pre-medicated.

• Subject is allergic to ALL antiplatelet treatments.

• Subject has impaired renal function (i.e. serum creatinine level =2.5 mg/dL).

• Subject is dialysis dependent.

• Subject is receiving immunosuppressant therapy.

• Subject has known or suspected active infection at the time of the index procedure.

• Subject has platelet count <100,000/mm3 or >700,000/mm3.

• Subject has history of gastrointestinal hemorrhage requiring a transfusion within 3 months prior to the study procedure.

• Subject is diagnosed with coagulopathy that precludes treatment with systemic anticoagulation and/or dual antiplatelet therapy (DAPT).

• Subject has history of stroke within the past 90 days.

• Subject has a history of myocardial infarction within the past 30 days.

• Subject is unable to tolerate blood transfusions because of religious beliefs or other reasons.

• Subject is incarcerated, mentally incompetent, or abusing drugs or alcohol.

• Subject is participating in another investigational drug or medical device study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints from this study, or subject is planning to participate in such studies prior to the completion of this study.

• Subject has had any major (e.g. cardiac, peripheral, abdominal) surgical procedure or intervention unrelated to this study within 30 days prior to the index procedure or has planned major surgical procedure or intervention within 30 days of the index procedure.

• Subject had previous bypass surgery of the target lesion.

• Subject had previous treatment of the target vessel with thrombolysis or surgery.

• Subject is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol.

• Target lesion has severe calcification (as defined by the PARC classification of calcification).

• Target lesion involves an aneurysm or is adjacent to an aneurysm (within 5 mm).

• Target lesion requires treatment with alternative therapy such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices, or subintimal dissection techniques.

• Significant target vessel tortuosity or other parameters prohibiting access to the target lesion.

• Presence of thrombus in the target vessel.

• Iliac inflow disease requiring treatment, unless the iliac artery disease is successfully treated first during the index procedure. Success is defined as =30% residual diameter stenosis without death or major complications.

• Presence of an aortic, iliac or femoral artificial graft.

Related Conditions & MeSH terms

• Artery Disease, Peripheral
• Femoropopliteal Artery Occlusion
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• Surmodics SurVeil DCB
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
• Medtronic IN.PACT Admiral DCB
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.

Locations

Country	Name	City	State
Australia	Prince of Wales Private Hostpital	Randwick
Austria	Institution Medizinische Universitat	Graz
Belgium	AZ Sint Blasius	Dendermonde
Belgium	UZ GENT	Ghent
Czechia	FN u sv. Anny v Brne a LF MU (Centrum cévních onemocnení II. chirurgická klinika)	Brno
Czechia	Vitkovicka Nemocnice Ostrava Vítkovická nemocnice, a.s.,	Ostrava
Germany	Herz Zentrum Bad Krozingen Südring	Bad Krozingen
Germany	SRH Klinikum KarlsbadLangensteinbach	Karlsbad
Germany	Universitätsklinikum Leipzig	Leipzig
Germany	REGIOMED-KLINIKEN GmbH	Sonneberg
Italy	Aou Careggi University Hospital	Florence
Latvia	Pauls Stradins Clinical University Hospital	Riga
New Zealand	Auckland City Hospital	Auckland
United States	Mission Hospital	Asheville	North Carolina
United States	Emory University Hospital (Clifton)	Atlanta	Georgia
United States	Piedmont Heart Insitute	Atlanta	Georgia
United States	St. David's Heart & Vascular PLLC dba Austin Heart	Austin	Texas
United States	Cardiovascular Associates of the Southeast	Birmingham	Alabama
United States	Endovascular Technologies, LLC	Bossier City	Louisiana
United States	Beth Israel Deaconess	Boston	Massachusetts
United States	St. Elizabeth's Medical Center	Boston	Massachusetts
United States	Capital Area Research	Camp Hill	Pennsylvania
United States	Virtua Medical Group, P.A.	Cherry Hill	New Jersey
United States	The Lindner Clinical Trial Center	Cincinnati	Ohio
United States	Clearwater Cardiovascular Consultants	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	Ohio Health Research Institute	Columbus	Ohio
United States	Cardiovascular Associates Research	Covington	Louisiana
United States	Alexian Brothers Medical Center	Elk Grove Village	Illinois
United States	North Ohio Heart Center	Elyria	Ohio
United States	Cardiology Associates	Foley	Alabama
United States	Mission Cardiovascular Research Institute	Fremont	California
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Dignity Health	Gilbert	Arizona
United States	Moses Cone-LeBauer	Greensboro	North Carolina
United States	Hattiesburg Clinic	Hattiesburg	Mississippi
United States	Houston Cardiovascular Association	Houston	Texas
United States	St Vincent Heart (Research Department)	Indianapolis	Indiana
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Ballad Health System	Kingsport	Tennessee
United States	Turkey Creek Medical Center	Knoxville	Tennessee
United States	North Dallas Research Associates	McKinney	Texas
United States	Advocate Health	Naperville	Illinois
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Columbia University Medical Center/NYPH	New York	New York
United States	St. Michael's Hospital	Newark	New Jersey
United States	Advent Health Ocala/MediQuest Research Group LLC (formerly FL Hospital /Munroe)	Ocala	Florida
United States	Oklahoma Cardiovascular Research Group	Oklahoma City	Oklahoma
United States	University of Nebraska	Omaha	Nebraska
United States	Northern Michigan Hospital	Petoskey	Michigan
United States	Bryn Mawr Hospital - Main Line Health System (Einstein)	Philadelphia	Pennsylvania
United States	Providence Heart and Vascular	Portland	Oregon
United States	The Miriam Hospital	Providence	Rhode Island
United States	North Carolina Heart and Vascular	Raleigh	North Carolina
United States	North Memorial Hospital	Robbinsdale	Minnesota
United States	Mercy Hospital	Springfield	Missouri
United States	Prairie Education (PERC)	Springfield	Illinois
United States	Holy Name Medical Center	Teaneck	New Jersey
United States	University of Toledo Medical Center	Toledo	Ohio
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Iowa Heart Center	West Des Moines	Iowa
United States	Pinnacle Health Cardiovascular Institute	Wormleysburg	Pennsylvania
United States	Yuma Regional Medical Center	Yuma	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
SurModics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Czechia,  Germany,  Italy,  Latvia,  New Zealand, 

References & Publications (5)

Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. doi: 10.1161/CIRCULATIONAHA.106.174526. No abstract available. — View Citation

Laird JR, Schneider PA, Tepe G, Brodmann M, Zeller T, Metzger C, Krishnan P, Scheinert D, Micari A, Cohen DJ, Wang H, Hasenbank MS, Jaff MR; IN.PACT SFA Trial Investigators. Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA. J Am Coll Cardiol. 2015 Dec 1;66(21):2329-2338. doi: 10.1016/j.jacc.2015.09.063. Epub 2015 Oct 14. — View Citation

Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available. — View Citation

Patel MR, Conte MS, Cutlip DE, Dib N, Geraghty P, Gray W, Hiatt WR, Ho M, Ikeda K, Ikeno F, Jaff MR, Jones WS, Kawahara M, Lookstein RA, Mehran R, Misra S, Norgren L, Olin JW, Povsic TJ, Rosenfield K, Rundback J, Shamoun F, Tcheng J, Tsai TT, Suzuki Y, Vranckx P, Wiechmann BN, White CJ, Yokoi H, Krucoff MW. Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC). J Am Coll Cardiol. 2015 Mar 10;65(9):931-41. doi: 10.1016/j.jacc.2014.12.036. Erratum In: J Am Coll Cardiol. 2015 Jun 16;65(23):2578-9. — View Citation

Rosenfield K, Jaff MR, White CJ, Rocha-Singh K, Mena-Hurtado C, Metzger DC, Brodmann M, Pilger E, Zeller T, Krishnan P, Gammon R, Muller-Hulsbeck S, Nehler MR, Benenati JF, Scheinert D; LEVANT 2 Investigators. Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease. N Engl J Med. 2015 Jul 9;373(2):145-53. doi: 10.1056/NEJMoa1406235. Epub 2015 Jun 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Lesion Patency Though 12 Months	Composite of freedom from clinically-driven target lesion revascularization (TLR) and binary restenosis (restenosis defined as duplex ultrasound [DUS] peak systolic velocity ratio [PSVR] =2.4 or =50% stenosis as assessed by independent angiographic and DUS core labs) through 12 months post-index procedure.	12 months
Primary	Safety Composite of Freedom From Death, Amputation, and Target Vessel Revascularization (TVR)	Composite of freedom from device- and procedure-related death through 30 days post-index procedure and freedom from major target limb amputation (above the ankle) and clinically-driven TVR through 12 months post-index procedure.	12 months
Secondary	Proportion of Participants With Device Success	Defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure, and achievement of <50% residual stenosis of the target lesion (by core lab-assessed quantitative angiography [QA]) without flow-limiting arterial dissection (= 50% residual stenosis or dissection grade E or F) using only the study device.	Day 0
Secondary	Proportion of Participants With Technical Success	Defined as achievement of a final residual diameter stenosis of <50% (by core lab-assessed QA) without flow-limiting arterial dissection at the end of the procedure.	Day 0
Secondary	Proportion of Participants With Procedure Success	Defined as evidence of both acute technical success and absence of Peripheral Academic Research Consortium major adverse events (PARC MAEs; e.g., death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and or need for urgent/emergent vascular surgery) within 72 hours of the index procedure.	72 hours
Secondary	Freedom From All-cause Death, Major Target Limb Amputation and TVR Through 30 Days	Proportion of participation free of all-cause death, major target limb amputation and TVR through 30 days. All clinical endpoints adjudications by independent, blinded CEC.	30 days
Secondary	Proportion of Participants With Primary Lesion Patency	Primary patency through 24 months (only if both the primary safety and efficacy hypotheses of noninferiority are met).	24 months
Secondary	Proportion of Participants With Target Vessel Patency	Defined as freedom from clinically-driven target vessel revascularization (TVR) and binary restenosis (restenosis defined as DUS PSVR =2.4 or =50% stenosis as assessed by independent angiographic and DUS core labs) within 12 and 24 months.	12 months, 24 months
Secondary	Proportion of Participants With Sustained Clinical Improvement	Defined as freedom from major target limb amputation, TVR and worsening target limb Rutherford class, within 6, 12, and 24 months.	6 months, 12 months, 24 months
Secondary	Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR)	Includes participants experiencing a clinically-driven target lesion revascularization event as reported by sites and adjudicated by an independent CEC.	6 months, 12 months, 24 months
Secondary	Proportion of Participants With a Historical Major Adverse Events (MAEs)	MAEs defined as composite of all-cause death, clinically-driven TLR, major target limb amputation, or thrombosis at the target lesion, within 6, 12, 24 months.	6 months, 12 months, 24 months
Secondary	Proportion of Participants With a Major Target Limb Amputation	Major target limb amputation within 6, 12, 24 months as reported by site and adjudicated by CEC.	6 months, 12 months, 24 months
Secondary	Proportion of Participants With a Thrombosis at the Target Lesion.	Thrombosis at target lesion within 6, 12, 24 months as reported by the site and adjudicated by the CEC.	6 months, 12 months, 24 months
Secondary	Change in Target Limb Rutherford Class	Change in target limb Rutherford class from Baseline (BL) to 1, 6, 12, and 24 months.; Rutherford classification criteria categorize the severity of chronic limb ischemia based on a clinical description of symptoms and pre-defined objective criteria.; Possible scores range from 0 to 6 with scores defined as follows: 0 - Asymptomatic - no hemodynamically significant occlusive disease; - Mild claudication; - Moderate claudication; - Severe claudication; - Ischemic rest pain; - Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia; - Major tissue loss, extending above transmetatarsal) with all scores defined as follows: Change = 1-Month scores - BL scores; 6-Month scores - BL scores; 12-Month scores - BL scores; 24-Month scores - BL scores	Baseline, 1 month, 6 months, 12 months, and 24 months
Secondary	Change in Target Limb Peripheral Academic Research Consortium (PARC) Class	Change in target limb PARC class from baseline to 1, 6, 12, and 24 months.; PARC definitions of clinical symptom classification were used to classify subject claudication at baseline and subsequent follow-up visits. PARC clinical symptom classification is used to capture information regarding lower extremity symptoms and broadly define functional limitations of patients with lower extremity peripheral artery disease (PAD).; Possible classifications include the following: Asymptomatic Mild claudication/limb symptoms (no limitation in walking) Moderate claudication/limb symptoms (able to walk without stopping > 2 blocks or 200 meters or 4 minutes) Severe claudication/limb symptoms (only able to walk without stopping < 2 blocks or 200 meters or 4 minutes) Ischemic rest pain (pain in the distal limb at rest, felt to be due to limited arterial perfusion) Ischemic ulcers on distal leg Ischemic gangrene; Change = 1-Month scores - BL scores; 6-Month scores - BL scores; 12-Mon	Screening, 1 month, 6 months, 12 months, and 24 months
Secondary	Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI)	Decrease in target limb resting ABI or TBI =0.15 from baseline to 6, 12, and 24 months.; Ankle-brachial index (ABI) is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial artery.; Toe brachial index (TBI) is the ratio of SBP measured at the toe to that measured at the brachial artery.; if ABI could not be assessed, TBI could be used.	Screening, 6 months, 12 months, and 24 months
Secondary	Change in Walking Impairment Questionnaire (WIQ)	Walking Impairment Questionnaire is a validated tool that has 4 domains (Walking Impairment, Walking Distance, Walking Speed, and Stair Climbing), each scored as a percent ranging from 0 (representing the inability to perform any of the tasks) to 100 (representing no difficulty with any of the tasks). A positive change in a score indicates an improvement.	Screening, 1 month, 12 months, and 24 months
Secondary	Change in 6-Minute Walk Test (6MWT)	Change in 6MWT from baseline to 12 and 24 months.	Screening, 12 months, and 24 months
Secondary	Change in Peripheral Artery Questionnaire (PAQ)	The PAQ consists of 7 domains including physical function, stability, symptom, treatment satisfaction, quality of life, social limitation, and summary. Scores range from 0 to 100, with a positive change indicating an improvement.	Screening, 1 month, 12 months, and 24 months
Secondary	Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR)	Includes participants experiencing a clinically-driven target lesion revascularization event as reported by sites and adjudicated by an independent CEC.	36 months, 48 months, 60 months
Secondary	Proportion of Participants With a Historical Major Adverse Events (MAEs)	MAEs defined as composite of all-cause death, clinically-driven TLR, major target limb amputation, or thrombosis at the target lesion within 36, 48, and 60 months.	36 months, 48 months, 60 months
Secondary	Proportion of Participants With a Major Target Limb Amputation	Major target limb amputation within 36, 48, and 60 months as reported by site and adjudicated by CEC.	36 months, 48 months, 60 months
Secondary	Proportion of Participants With a Thrombosis at the Target Lesion	Thrombosis at target lesions within 36, 48, and 60 months as reported by the site and adjudicated by the CEC.	36months, 48 months, 60 months