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

Completed · Not applicable

Conditions studied: Peripheral Artery Disease

In brief

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.

Key facts

Study ID

NCT02522884

Run by

Philips Clinical & Medical Affairs Global

People needed

213

Starts

2015-09-01

Expected to finish

2020-03-01

Last updated by the study team

2021-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must meet all of the following inclusion criteria to be eligible for enrollment:
• Male or non-pregnant Female ≥ 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 through the duration of the study (abstinence is acceptable)
• Target limb requires no additional treatment aside from the target lesion and the iliac artery(ies) during the index procedure
• 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
• Willing to comply with all required follow-up visits
• Rutherford Classification 2, 3 or 4
• Estimated life expectancy >1 year
• Eligible for standard surgical repair, if necessary
• Subject is ambulatory (assistive devices such as a cane or walker is acceptable)

You may not qualify if…

• Subject must NOT meet any of the following exclusion criteria to be eligible for enrollment:
• Rutherford Classification 0, 1, 5 or 6
• Is pregnant or refuses to use contraception through the duration of the study
• Previous infrainguinal bypass graft in the target limb
• Planned amputation on the target limb
• Systemic infection or Infection within the target limb and/or immunocompromised
• 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
• 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
• 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
• Any other previous or planned surgical or endovascular procedure (not including diagnostic procedures) within 14 days prior to or 30 days post index procedure
• 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
• Known coagulopathy, hypercoagulable state, bleeding diathesis, other blood disorder, or a platelet count less than 80,000/microliter or greater than 500,000/microliter
• Known hypersensitivity or allergy to antiplatelet or anticoagulant therapy
• Myocardial infarction within 30 days prior to enrollment
• History of stroke within 90 days prior to enrollment
• Serum creatinine of >2.5 mg/dL
• 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
• Known hypersensitivity or contraindication to nickel-titanium alloy (Nitinol)
• Participating in another ongoing investigational clinical trial that has not completed its primary endpoint
• 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
• Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved

Where it is running

• 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

Full record on ClinicalTrials.gov

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