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

Not Applicable

Completed

Conditions: Peripheral Arterial Disease

Registration Number: NCT02942966

Lead Sponsor: Philips Clinical & Medical Affairs Global

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 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 233

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacy - Number of Participants With Freedom From MALE at 6 Months and POD at 30 Days	6 months	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.
Safety - Number of Participants With MALE Plus POD at 30 Days	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

Secondary Outcome Measures

Name	Time	Method
Patency - Number of Target Lesion(s) Tacked Segment(s) Patent at 6 Months	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.
Target Limb Salvage - Number of Participants With Freedom From Above-Ankle Target Limb Amputation at 6 Months	6 months	Target Limb Salvage defined as freedom from any above-ankle target limb amputation at 6 months.

Trial Locations

Locations (49): 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, 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
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Yuma Regional Medical Center
🇺🇸Yuma, Arizona, United States