Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries

Peripheral Arterial Disease Clinical Trial

— TOBA II BTK  

Official title:

Tack Optimized Balloon Angioplasty Study for the Below The Knee Arteries Using the Tack Endovascular System®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02942966
• Other study ID #: CA 0137
• Status: Completed
• Phase: N/A
• Start date: February 8, 2017
• Est. completion date: January 10, 2022

Study information

• Verified date: April 2021
• Source: Philips Clinical & Medical Affairs Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in the Mid/Distal Popliteal, Tibial, and Peroneal Arteries ranging in diameter from 1.5mm to 4.5mm for the treatment of post percutaneous transluminal balloon angioplasty (PTA) dissection(s) requiring repair.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: January 10, 2022
• Est. primary completion date: July 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males or non-pregnant females = 18 years of age at the time of consent

• Female subjects of childbearing potential must have a negative pregnancy test prior to treatment and must use some form of contraception (abstinence is acceptable) through the duration of the study

• Subject has been informed of and understands the nature of the study and provides signed informed consent to participate in the study. If the subject possesses the ability to understand and provide informed consent but due to physical inability, the subject cannot sign the informed consent form (ICF), an impartial witness may sign on behalf of the subject

• Willing to comply with all required follow-up visits

• Rutherford Classification 4 or 5.

• WIfI Wound grade of 0, 1 or modified 2.

• WIfI Foot Infection grade of 0 or 1.

• Estimated life expectancy =1 year

Exclusion Criteria:

• Is pregnant or refuses to use contraception through the duration of the study

• Previous bypass graft in the target limb

• Acute limb ischemia, defined as symptom onset occurring less than 14 days prior to the index procedure

• Prior or planned above-ankle amputation or complete transmetatarsal amputation to the target limb (this does not apply to ray amputation of =2 digits, simple digital amputations or ulcer debridements)

• WIfI Foot Infection grade 2 or 3

• Any systemic infection or immunocompromised state. Patients with an ascending infection/deep foot infection or abscess/white blood count (WBC)=12,000/or febrile state

• Endovascular or surgical procedure (not including diagnostic procedures, planned simple digital amputation or wound debridement) to the target limb less than 30 days prior to or planned for less than 30 days after the index procedure

• Existing stent implant in the target vessel

• Any other endovascular or surgical procedure (not including diagnostic procedures, planned simple digital amputation or wound debridement) less than 14 days prior to the index procedure or planned procedure less than 30 days after the index procedure

• Known coagulopathy, hypercoagulable state, bleeding diathesis, other blood disorder, or a platelet count less than 80,000/microliter or greater than 500,000/microliter

• WIfI Wound grade of 2 or 3.

• Any subject in which antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated

• Myocardial infarction, coronary thrombolysis or angina less than 30 days prior to the Index Procedure

• History of stroke or transient ischemic attack (TIA) less than 90 days prior to the Index Procedure

• Currently on dialysis

• Known hypersensitivity or contraindication to nickel-titanium alloy (Nitinol)

• Participating in another ongoing investigational clinical trial in which the subject has not completed the primary endpoint(s)

• Has other comorbidities that, in the opinion of the investigator, would preclude them from receiving this treatment and/or participating in study-required follow-up assessments

• Known hypersensitivity or allergy to contrast agents that cannot be medically managed

• Subject already enrolled into this study

• Restenotic target lesion previously treated by means other than plain balloon angioplasty and/or less than 1 year prior to index procedure.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Tack Endovascular System
Repair of post-PTA dissections using the Intact Vascular Tack Endovascular System.

Locations

Country	Name	City	State
Austria	Division of Angiology, Medical University Graz	Graz
Czechia	St. Anne's University Hospital Brno	Brno
Germany	Karolinen-Hospital	Arnsberg
Germany	Franziskus-Hospital Berlin-Radiology	Berlin
Germany	Westküstenklinikum Heide	Heide
Germany	Universitätsklinikum Leipzig	Leipzig
Germany	Evangelisches Krankenhaus Mülheim an der Ruhr	Mülheim an der Ruhr
Germany	Krankenhaus Buchholz	Nordheide
Germany	MEDINOS Kliniken des Landkreises Sonneberg GmbH	Sonneberg
Hungary	Heart & Vascular Center - Semmelweis University	Budapest
Hungary	Bács-Kiskun County Hospital	Kecskemét
New Zealand	Auckland Hospital	Auckland
United States	New Mexico Heart Institute, PA	Albuquerque	New Mexico
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Lake Washington Vascular, PLLC	Bellevue	Washington
United States	Deborah Heart and Lung Center	Browns Mills	New Jersey
United States	Lindner Research Center	Cincinnati	Ohio
United States	University Hospitals, Cleveland Medical Center	Cleveland	Ohio
United States	Palmetto Health USC Medical Group	Columbia	South Carolina
United States	Ohio Health Research Institute	Columbus	Ohio
United States	Midwest Cardiovascular Research Foundation	Davenport	Iowa
United States	Denver VA Medical Center	Denver	Colorado
United States	Ascension St. John Hospital	Detroit	Michigan
United States	Amita Health Cardiovascular Associates	Elk Grove Village	Illinois
United States	Michigan Vascular Center	Flint	Michigan
United States	Mission Cardiovascular Research Institute	Fremont	California
United States	University of Texas Medical Branch at Galveston	Galveston	Texas
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	Baylor College of Medicine	Houston	Texas
United States	Kore Cardiovascular Research	Jackson	Tennessee
United States	First Coast Cardiovascular Institute	Jacksonville	Florida
United States	Novant Health Heart and Vascular Institute	Matthews	North Carolina
United States	North Dallas Research Associates	McKinney	Texas
United States	Centennial Medical Center	Nashville	Tennessee
United States	Mission Research Institute	New Braunfels	Texas
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Sentara Vascular Specialists	Norfolk	Virginia
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Einstein Healthcare Network	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	The Miriam Hospital	Providence	Rhode Island
United States	Rex Hospital	Raleigh	North Carolina
United States	WakeMed Hospital	Raleigh	North Carolina
United States	St. Louis Heart & Vascular	Saint Louis	Missouri
United States	Holy Name Medical Center	Teaneck	New Jersey
United States	Cardiovascular Associates of East Texas	Tyler	Texas
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Yuma Regional Medical Center	Yuma	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Countries where clinical trial is conducted

United States,  Austria,  Czechia,  Germany,  Hungary,  New Zealand, 

References & Publications (2)

Conte MS, Geraghty PJ, Bradbury AW, Hevelone ND, Lipsitz SR, Moneta GL, Nehler MR, Powell RJ, Sidawy AN. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg. 2009 Dec;50(6):1462-73.e1-3. doi: 10.1016/j.jvs.2009.09.044. Epub 2009 Nov 7. Review. — View Citation

Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy - Number of Participants With Freedom From MALE at 6 Months and POD at 30 Days	Freedom from major adverse limb events (MALE) at 6 months defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death (POD) at 30 days.	6 months
Primary	Safety - Number of Participants With MALE Plus POD at 30 Days	Major adverse limb events (MALE) at 30 days defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death at 30 days	30 days
Secondary	Patency - Number of Target Lesion(s) Tacked Segment(s) Patent at 6 Months	Target lesion(s) tacked segment(s) patency at 6 months defined as the presence of blood flow using duplex ultrasound. If angiography is available within the 6 month follow-up visit window, it should be used in place of the duplex ultrasound. Evidence of no blood flow within the Tacked segment indicates restenosis/loss of patency.	6 months
Secondary	Target Limb Salvage - Number of Participants With Freedom From Above-Ankle Target Limb Amputation at 6 Months	Target Limb Salvage defined as freedom from any above-ankle target limb amputation at 6 months.	6 months