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

Study Overview
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Brief Summary
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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.

Official Title
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Tack Optimized Balloon Angioplasty Study for the Below The Knee Arteries Using the Tack Endovascular System®

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Tack Endovascular System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tack Implant<br>Implantation of a Tack using the Intact Vascular Tack Endovascular System for the repair of post angioplasty dissections below the knee. | Device: Tack Endovascular System<br>* Repair of post-PTA dissections using the Intact Vascular Tack Endovascular System.<br>* Other names: Tack Dissection Repair Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - Number of Participants With Freedom From MALE at 6 Months and POD at 30 Days | 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. | 6 months | 
| Safety - Number of Participants With MALE Plus POD at 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 | 30 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angioplasty, Below the Knee, PAD, Critical Limb Ischemia, Lesion, Claudication