SELUTION4SFA Trial

Peripheral Arterial Disease Clinical Trial

Official title:

A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Efficacy of the SELUTION SLR™ 018 Drug Eluting Balloon in the Treatment of Subjects With Femoropopliteal Artery Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05132361
• Other study ID #: S2020-02
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 1, 2029

Study information

• Verified date: May 2024
• Source: M.A. Med Alliance S.A.
• Contact: Anna Hubert
• Phone: +1(630)7294530
• Email: anna.hubert[@]cordis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to demonstrate the safety and efficacy of the SELUTION SLR™ 018 DEB compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 1, 2029
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Clinical Inclusion Criteria:

1. Subject age is = 18 years or minimum legal age as required by local regulations.

2. Life expectancy >1 year in opinion of investigator.

3. Documented ischemia with Rutherford classification category 2, 3 or 4.

4. Target lesion(s) in the SFA or PPA.

5. Able to walk without the assistance of a walker.

6. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.

7. Female subjects only: If female, then subjects of childbearing potential must have a negative pregnancy test = 7 days before the procedure and be prepared to use effective contraception for 12 months after treatment.

Angiographic Inclusion Criteria:

1. Angiographic evidence that target lesion lies within the superficial femoral artery and/or proximal popliteal artery (P1 and P2 only).

2. Angiographic evidence that the target lesion consists of either a de novo lesion or a non-stented restenotic lesion, or a combination of both, that meets one of the following criteria: A. A stenosis of 70-99% with lesion length between =3cm and <20cm by visual estimation. B. A total (100%) occlusion with lesion length between =3cm and =10cm by visual estimation. C. A combination lesion (stenosis and total occlusion) must have a total lesion length between =3cm and <20cm by visual estimation with an occluded segment that is =10cm by visual estimation. D. If multiple lesions are to be treated, then only 2 lesions may be included. The total combination of lengths must be between =3cm and < 20cm by visual estimation, and there must be at least 5 cm of artery that is not to be treated between them.

3. Target vessel reference diameter =4mm and =7mm.

4. Patent arterial inflow (common iliac, external iliac, common femoral and profunda femoris arteries, and the proximal 2 cm of the SFA) free from significant lesion (defined as =50% stenosis) as confirmed on angiography. Note: Where required, inflow iliac arteries (common and external iliac arteries only) must be successfully treated during the index procedure. Completion angiography must confirm successful treatment of inflow disease (=30% residual stenosis, no distal embolization, and no Grade C or greater dissection ) prior to pre-dilation and randomization of the target lesion(s). Drug-eluting devices are not allowed for treatment of the occluded inflow iliac arteries.

5. Angiographic evidence of adequate distal run off (defined as =50% stenosis) in one or more tibial arteries on initial angiography, and if applicable, after completion of inflow artery treatment. Note: Treatment of outflow disease is permitted during the index procedure. Drug-eluting devices are not allowed for outflow treatment.

Clinical Exclusion Criteria:

1. Other surgical or endovascular procedure in the target limb that occurred within 14 days prior to index procedure or is planned for within 30 days following index procedure, with exception for diagnostic angiography.

2. Inability to tolerate dual antiplatelet therapy.

3. Known hypersensitivity or allergy to Sirolimus or other pharmacologic agents, such as contrast agent, which are required for the procedure and which cannot be adequately pre-treated.

4. Stroke or MI within 3 months of enrollment.

5. Symptom onset less than 14 days prior to index procedure (acute limb ischemia).

6. Lower limb disease in the contralateral leg that requires treatment at the index procedure, or, that is planned within 14 days prior to the index procedure or within 30 days after the index procedure.

7. Prior vascular surgery (including bypass and endarterectomy) of abdominal aorta, iliac arteries, or arteries of the index limb.

8. Non-atherosclerotic disease of the index limb (including aneurysmal disease, vasculitis, Buerger's disease)

9. Target lesion requires treatment with alternative therapies such as thrombolysis, thrombus aspiration, cutting/scoring/contoured balloon, stenting, laser, cryoplasty, intravascular lithotripsy, brachytherapy, re-entry device).

10. Subject has target lesion(s) that require treatment via pedal site.

11. Subject has target lesion(s) that require access via upper extremity arteries.

12. Hypercoagulable state or disorder present, or coagulopathy present, including platelet count less than 80,000 per microliter.

13. Chronic renal insufficiency (dialysis dependent, or serum creatinine >2.5 mg/dL within 30 days of index procedure).

14. Systemic infection (WBC > 12,000 and febrile) or known immune compromise.

15. Breast-feeding woman.

16. Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.

Angiographic Exclusion Criteria:

1. Presence of a previously placed stent in the treated artery.

2. Failure to successfully cross the target lesion.

3. Residual stenosis =30% after pre-dilatation.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Superficial Femoral Artery Stenosis

Intervention

Device:
• SELUTION SLR™ 018 DEB
a non-surgical procedure that uses a catheter to inflate a drug-eluting balloon to open up above the-knee arteries that have been narrowed due to peripheral arterial disease.
• Plain (Uncoated) Balloon Angioplasty (PTA)
a non-surgical procedure that uses a catheter to inflate a commercially available, non-drug-eluting balloon to open up above the-knee arteries that have been narrowed due to peripheral arterial disease.

Locations

Country	Name	City	State
Germany	Universitäts-Herzzentrum Freiburg - Bad Krozingen	Bad Krozingen
Germany	Krankenhaus Buchholz	Buchholz
Germany	Universitätsklinikum Leipzig	Leipzig
Germany	RoMed Klinikum Rosenheim	Rosenheim
Germany	University Clinic Tübingen	Tübingen
Hong Kong	The Chinese University of Hong Kong	Sha Tin
United States	Emory University Hospital	Atlanta	Georgia
United States	Manatee Memorial Hospital	Bradenton	Florida
United States	James J. Peters VA Medical Center	Bronx	New York
United States	Cleveland Clinic	Cleveland	Ohio
United States	OhioHealth Riverside Hospital	Columbus	Ohio
United States	Vascular Care Group	Darien	Connecticut
United States	Vascular Institute of the Midwest	Davenport	Iowa
United States	Mission Cardiovascular Research Institute	Fremont	California
United States	The Cardiac and Vascular Institute Research Foundation	Gainesville	Florida
United States	Cardiovascular Institute of the South	Gray	Louisiana
United States	Baylor College of Medicine	Houston	Texas
United States	MedStar Health Research Institute	Hyattsville	Maryland
United States	First Coast Cardiovascular Institute	Jacksonville	Florida
United States	St. Bernards Medical Center	Jonesboro	Arkansas
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	Palm Vascular Centers	Miami Beach	Florida
United States	Yale University	New Haven	Connecticut
United States	Mount Sinai	New York	New York
United States	Advocate Lutheran General Hospital	Park Ridge	Illinois
United States	Miriam Hospital	Providence	Rhode Island
United States	NC Heart and Vascular Research, LLC	Raleigh	North Carolina
United States	St. Helena Hospital	Saint Helena	California
United States	Mercy Hospital	Saint Louis	Missouri
United States	Texas Cardiac and Vascular Institute San Antonio	San Antonio	Texas
United States	Holy Name Medical Center	Teaneck	New Jersey
United States	Cardiovascular Consultants of South Georgia	Thomasville	Georgia
United States	ClinRé	Thornton	Colorado
United States	Tennessee Center for Clinical Trials	Tullahoma	Tennessee
United States	Guardian Research Organization, LLC	Winter Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
MedAlliance, LLC	NAMSA

Countries where clinical trial is conducted

United States,  Germany,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Efficacy Endpoint	Primary patency of the target lesion defined as freedom from ANY of the following adverse events: Clinically driven target lesion revascularization (CD-TLR, defined as re-intervention of target lesion(s) due to recurrent, persistent, or worsening symptoms and angiographic restenosis (= 50% diameter stenosis) of target lesion by ACL measurement) OR; Restenosis as determined by core lab adjudicated duplex ultrasound peak systolic velocity ratio of >2.4 or occlusion of the target lesion.	12 months
Primary	Primary Safety Endpoint	The primary safety endpoint is the freedom from ANY of the following adverse events: All-cause perioperative death (POD) [evaluated at 30 days] OR; Target limb major (above-the-ankle) amputation [evaluated at 12 months] OR; Clinically driven target lesion revascularization (CD-TLR) [evaluated at 12 months]	30 days or 12 months
Secondary	Powered Secondary Endpoints	If both primary endpoints are met, the following endpoint will be tested for superiority in a sequential manner: • Clinically driven target lesion revascularization (CD-TLR)	12 months
Secondary	Device success	A secondary performance endpoint defined as successful delivery, balloon inflation, deflation, and retrieval of the intact investigational device.	Immediately following the procedure
Secondary	Procedural (technical) success	A secondary performance endpoint defined as device success and residual diameter stenosis = 30% on completion angiography by core lab assessment.	Immediately following the procedure
Secondary	Clinical success	A secondary performance endpoint defined as procedural success without procedural complications (death, above-ankle target limb amputation, thrombosis of the target lesion or TLR) prior to discharge.	Discharge defined as immediately prior to hospital discharge from the index procedure or within 7 days, whichever occurs first
Secondary	Secondary Safety Endpoints	Major adverse limb events (MALE).; Major cardiovascular events, myocardial infarction (MI), and stroke.; All-cause mortality.	1, 6, and 12 months, and 2-5 years
Secondary	Primary sustained clinical improvement	A secondary efficacy endpoint defined as freedom from target limb major amputation and CD-TLR AND increase in Rutherford category from baseline.	1, 6, and 12 months, and 2-5 years
Secondary	Secondary sustained clinical improvement	A secondary efficacy endpoint defined as freedom from target limb major amputation AND increase in Rutherford category from baseline.; Major amputation, defined as above-the-ankle amputation of the target limb.; Amputation-free survival, defined as freedom from all-cause mortality and major amputation.	1, 6, and 12 months, and 2-5 years
Secondary	Major amputation	A secondary efficacy endpoint defined as above-the-ankle amputation of the target limb.	1, 6, and 12 months, and 2-5 years
Secondary	Amputation-free survival	A secondary efficacy endpoint defined as freedom from all-cause mortality and major amputation.	1, 6, and 12 months, and 2-5 years
Secondary	Primary assisted patency	A secondary efficacy endpoint defined as freedom from target lesion occlusion by duplex ultrasound core laboratory [DCL] adjudication), irrespective of interventions for stenoses.	12 and 24 months
Secondary	Secondary patency	A secondary efficacy endpoint defined as freedom from permanent occlusion (occlusion at the last follow-up imaging) as determined by the DCL.; Freedom from CD-TLR and binary restenosis as determined by the DCL [at 1, 3, 6, 12, 24, 36 months].; Any TLR, defined as any re-intervention of target lesion(s) 1, 6, and 12 months, and 2-5 years	12 and 24 months
Secondary	Freedom from CD-TLR and binary restenosis	A secondary efficacy endpoint defined as freedom from Clinically driven target lesion revascularization and binary restenosis as determined by the duplex ultrasound core laboratory (DCL).	1, 3, 6, 12, 24, 36 months
Secondary	Any TLR	A secondary efficacy endpoint defined as any re-intervention of target lesion(s).	1, 6, and 12 months, and 2-5 years
Secondary	CD-TLR	A secondary efficacy endpoint defined as re-intervention of target lesion(s) due to recurrent/persistent/worsening symptoms and the angiographic finding of = 50% restenosis of target lesion by ACL measurement.	1, 6, and 12 months, and 2-5 years
Secondary	Clinically driven Target Vessel Revascularization (TVR)	A secondary efficacy endpoint defined as re-intervention of target vessel due to recurrent/persistent/worsening symptoms and the angiographic finding of = 50% restenosis of target vessel by ACL measurement.	1, 6, and 12 months, and 2-5 years
Secondary	Target lesion thrombosis	A secondary efficacy endpoint assessed by angiographic or DUS core laboratory adjudication.	1, 6, and 12 months, and 2-5 years
Secondary	Rutherford category	A secondary efficacy endpoint defined as change in Rutherford category from baseline.	1, 6, 12, 24 and 36 months
Secondary	Ankle brachial index (ABI)	A secondary efficacy endpoint defined as change in ankle brachial index (ABI) from baseline.	12 and 24 months
Secondary	Walking capacity	A secondary efficacy endpoint defined as change in Walking capacity assessed by Walking Impairment Questionnaire (WIQ) from baseline.	1, 6, 12, 24 and 36 months
Secondary	Secondary Imaging endpoints (DCL adjudicated):	Primary duplex-defined binary restenosis - Peak Systolic Velocity Ratio (PSVR)>2.4.; Alternate duplex-defined binary restenosis - Peak Systolic Velocity Ratio (PSVR)>3.4.	12 and 24 months
Secondary	Secondary Quality of life and health economic assessments (1)	• Change in EQ-5D score from baseline. OBS.: Following EuroQol terminology: Scores are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead.	12 months
Secondary	Secondary Quality of life and health economic assessments (2)	• Days of target lesion-related hospitalization at 12 months.	12 months