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

NCT ID: NCT02522884

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2020-03-31

Brief 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.

Conditions

Peripheral Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tack Implant

Implantation of a Tack using the Intact Vascular Tack Endovascular System for the repair of post angioplasty dissections.

Group Type: EXPERIMENTAL

Tack Endovascular System

Intervention Type: DEVICE

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

Interventions

Tack Endovascular System

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

Intervention Type: DEVICE

Other Intervention Names

Post-PTA Dissection Repair Implant; Tack Implant; Tack Dissection Repair Device

Eligibility Criteria

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

12. Known hypersensitivity or allergy to antiplatelet or anticoagulant therapy

13. Myocardial infarction within 30 days prior to enrollment

14. History of stroke within 90 days prior to enrollment

15. Serum creatinine of >2.5 mg/dL

16. Requires treatment of tibial or outflow vessels at the index procedure, which include the P2 and P3 segments of the popliteal artery and the tibioperoneal vessels

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

18. Participating in another ongoing investigational clinical trial that has not completed its primary endpoint

19. 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

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

21. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Clinical & Medical Affairs Global

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William A. Gray, MD

Role: PRINCIPAL_INVESTIGATOR

Main Line Health/Lankenau Heart Institute

Locations

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

Adventist Midwest Health

LaGrange, Illinois, United States

Prairie Education and Research Cooperative

Springfield, Illinois, United States

Midwest Cardiovascular Research Foundation

Davenport, Iowa, United States

University of Iowa

Iowa City, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Metro Health Hospital

Wyoming, Michigan, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

New Mexico Heart Institute, PA

Albuquerque, New Mexico, United States

NC Heart and Vascular Research

Raleigh, North Carolina, United States

NC Heart and Vascular Research - WakeMed Raleigh

Raleigh, North Carolina, United States

Ohio Health Research Institute

Columbus, Ohio, United States

Holy Spirit Cardiology

Camp Hill, Pennsylvania, United States

St. Mary Medical Center

Langhorne, Pennsylvania, United States

Einstein Medical Center Philadelphia

Philadelphia, Pennsylvania, United States

Pinnacle Health Cardiovascular Institute

Wormleysburg, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

The Miriam Hospital

Providence, Rhode Island, United States

Medical University of South Carolina

Charleston, South Carolina, United States

North Central Heart

Sioux Falls, South Dakota, United States

Wellmont CVA Heart Institute

Kingsport, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

North Dallas Research Associates

McKinney, Texas, United States

Mission Research Institute

New Braunfels, Texas, United States

Sentara Vascular Specialists

Norfolk, Virginia, United States

Medical University Hospital Graz

Graz, , Austria

Hanusch Krankenhaus

Vienna, , Austria

St. Antonius Hospital

Nieuwegein, Utrecht, Netherlands

Countries

United States; Austria; Netherlands

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CA 0119

Identifier Type: -

Identifier Source: org_study_id