Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries (TOBA II BTK)

Philips

Status

Completed

Conditions

Peripheral Arterial Disease

Treatments

Device: Tack Endovascular System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02942966

CA 0137

Details and patient eligibility

About

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.

Enrollment

233 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.