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Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries | Clinical Trials | Clareo Health

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Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries

Tack Optimized Balloon Angioplasty Study for Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System™

NCT02522884•Philips Clinical & Medical Affairs Global

View on ClinicalTrials.gov

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 subjects with post-balloon angioplasty (post-PTA) dissection(s) type(s) A through F in the superficial femoral and proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or non-pregnant Female ≥ 18 years of age at the time of consent
•2. Female subjects of childbearing potential must have a negative pregnancy test prior to treatment and must use some form of contraception through the duration of the study (abstinence is acceptable)
•3. Target limb requires no additional treatment aside from the target lesion and the iliac artery(ies) during the index procedure
•4. Subject or 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, an impartial witness may sign on behalf of the subject
•5. Willing to comply with all required follow-up visits
•6. Rutherford Classification 2, 3 or 4
•7. Estimated life expectancy \>1 year
•8. Eligible for standard surgical repair, if necessary
•9. Subject is ambulatory (assistive devices such as a cane or walker is acceptable)

Exclusion Criteria

•1. Rutherford Classification 0, 1, 5 or 6
•2. Is pregnant or refuses to use contraception through the duration of the study
•3. Previous infrainguinal bypass graft in the target limb
•4. Planned amputation on the target limb
•5. Systemic infection or Infection within the target limb and/or immunocompromised
•6. Endovascular or surgical procedure (not including diagnostic procedures) on the target limb within 30 days prior to or within 30 days after the index procedure
•7. Endovascular or surgical procedure (not including diagnostic procedures) on the non-target limb within 14 days prior to the index procedure or planned procedure within 30 days after the index procedure
•8. Prior coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) procedure within 30 days prior to the index procedure or planned CABG/PCI within 30 days after the index procedure
•9. Any other previous or planned surgical or endovascular procedure (not including diagnostic procedures) within 14 days prior to or 30 days post index procedure
•10. Planned atherectomy, cryoplasty, stenting or any other treatment (with the exception of a crossing device) of the target lesion other than PTA during the index procedure
+11 more criteria

Locations (39)

Yuma Regional Medical Center

Yuma, Arizona, United States

Central Arkansas Veteran's Healthcare System

Little Rock, Arkansas, United States

Cedars Sinai Medical Center

Beverly Hills, California, United States

Mission Cardiovascular Research Institute

Fremont, California, United States

St. Joseph Hospital

Orange, California, United States

Denver VA Medical Center

Denver, Colorado, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Florida Research Network, LLC

Gainesville, Florida, United States

Alexian Brothers Medical Center Heart & Vascular Institute

Elk Grove Village, Illinois, United States

Key Dates

Start Date

September 1, 2015

Primary Completion Date

May 1, 2018

Completion Date

March 1, 2020

Last Updated

April 27, 2021

Enrollment

213

ACTUAL participants

Conditions

Peripheral Artery Disease

Interventions

Tack Endovascular System

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries

Inclusion Criteria

Exclusion Criteria

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