Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries
- Conditions
- Peripheral Artery Disease
- Interventions
- Device: Tack Endovascular System
- Registration Number
- NCT02522884
- 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 subjects with post-balloon angioplasty (post-PTA) dissection(s) type(s) A through F in the superficial femoral and proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 213
-
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 (abstinence is acceptable)
- 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 Informed Consent Form, 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)
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tack Implant Tack Endovascular System Implantation of a Tack using the Intact Vascular Tack Endovascular System for the repair of post angioplasty dissections.
- Primary Outcome Measures
Name Time Method Efficacy - Number of Subjects That Met Primary Patency Criteria at 12 Months 12 Months Primary patency defined as freedom from Clinical Events Committee (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 peak systolic velocity ratio (PSVR) \>2.5)
Safety - Number of Subjects That Met the Primary Safety Criteria of Freedom From Major Adverse Events at 30 Days 30 Days 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (39)
NC Heart and Vascular Research - WakeMed Raleigh
🇺🇸Raleigh, North Carolina, United States
Yuma Regional Medical Center
🇺🇸Yuma, Arizona, United States
Central Arkansas Veteran's Healthcare System
🇺🇸Little Rock, Arkansas, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Cedars Sinai Medical Center
🇺🇸Beverly Hills, California, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Denver VA Medical Center
🇺🇸Denver, Colorado, United States
Mission Cardiovascular Research Institute
🇺🇸Fremont, California, United States
St. Joseph Hospital
🇺🇸Orange, California, United States
Alexian Brothers Medical Center Heart & Vascular Institute
🇺🇸Elk Grove Village, Illinois, United States
Florida Research Network, LLC
🇺🇸Gainesville, Florida, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Hanusch Krankenhaus
🇦🇹Vienna, Austria
Midwest Cardiovascular Research Foundation
🇺🇸Davenport, Iowa, United States
Adventist Midwest Health
🇺🇸LaGrange, Illinois, United States
Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States
Metro Health Hospital
🇺🇸Wyoming, Michigan, United States
New Mexico Heart Institute, PA
🇺🇸Albuquerque, New Mexico, United States
NC Heart and Vascular Research
🇺🇸Raleigh, North Carolina, United States
Holy Spirit Cardiology
🇺🇸Camp Hill, Pennsylvania, United States
St. Mary Medical Center
🇺🇸Langhorne, Pennsylvania, United States
Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States
Pinnacle Health Cardiovascular Institute
🇺🇸Wormleysburg, Pennsylvania, United States
Einstein Medical Center Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
North Central Heart
🇺🇸Sioux Falls, South Dakota, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Wellmont CVA Heart Institute
🇺🇸Kingsport, Tennessee, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
North Dallas Research Associates
🇺🇸McKinney, Texas, United States
Medical University Hospital Graz
🇦🇹Graz, Austria
Mission Research Institute
🇺🇸New Braunfels, Texas, United States
Sentara Vascular Specialists
🇺🇸Norfolk, Virginia, United States
St. Antonius Hospital
🇳🇱Nieuwegein, Utrecht, Netherlands
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States