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

Study Overview
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Brief Summary
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This is an Outside the United States, post-CE Mark, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System. This study will evaluate subjects with PAD who receive PTA (with a drug-coated balloon (DCB)) in the SFA and in popliteal arteries, ranging in diameter from 2.5mm to 6.0mm and lesion lengths of ≥20mm and ≤150mm, and have a resulting dissection(s) type(s) A through F. TOBA III will also evaluate the safety and efficacy of the device when used to treat a sub-group presenting with longer lesions of >150mm and ≤250mm.

Official Title
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Tack Optimized Drug Coated Balloon Angioplasty in the Superficial Femoral and Proximal Popliteal 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: 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 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 ICF, 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 Exclusion Criteria: 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

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 implant using the Intact Vascular Tack Endovascular System for the repair of post DCB-angioplasty dissections. | 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 |
| --- | --- | --- |
| Safety - Freedom from the occurrence of any new-onset major adverse event(s) | Freedom from the occurrence of any new-onset major adverse event(s) (MAEs) defined as index limb amputation (above the ankle), CEC adjudicated clinically-driven target lesion revascularization (CD-TLR), or all-cause death at 30 days. | 30 days | 
| Efficacy - Primary Patency | Primary patency defined as freedom from CEC adjudicated clinically driven target lesion revascularization (CD-TLR) and freedom from core lab adjudicated duplex ultrasound derived binary restenosis at 12 months (defined as PSVR >2.5:1). | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angioplasty, Peripheral Artery Disease, PAD, Lesion, Claudication