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

Completed · Not applicable

Conditions studied: Peripheral Arterial 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 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.

Key facts

Study ID

NCT02942966

Run by

Philips Clinical & Medical Affairs Global

People needed

233

Starts

2017-02-08

Expected to finish

2022-01-10

Last updated by the study team

2022-01-31

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Yuma Regional Medical Center — Yuma, Arizona, United States
• Mission Cardiovascular Research Institute — Fremont, 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
• First Coast Cardiovascular Institute — Jacksonville, Florida, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• Amita Health Cardiovascular Associates — Elk Grove Village, Illinois, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• Midwest Cardiovascular Research Foundation — Davenport, Iowa, United States
• Cardiovascular Institute of the South — Houma, Louisiana, United States
• Ascension St. John Hospital — Detroit, Michigan, United States
• Michigan Vascular Center — Flint, Michigan, United States
• St. Louis Heart & Vascular — St Louis, Missouri, United States
• Deborah Heart and Lung Center — Browns Mills, New Jersey, United States
• Holy Name Medical Center — Teaneck, New Jersey, United States
• New Mexico Heart Institute, PA — Albuquerque, New Mexico, United States
• Novant Health Heart and Vascular Institute — Matthews, North Carolina, United States
• Rex Hospital — Raleigh, North Carolina, United States
• WakeMed Hospital — Raleigh, North Carolina, United States
• Lindner Research Center — Cincinnati, Ohio, United States
• University Hospitals, Cleveland Medical Center — Cleveland, Ohio, United States
• Ohio Health Research Institute — Columbus, Ohio, United States
• Einstein Healthcare Network — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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