Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries
- Conditions
- Peripheral Arterial Disease
- Interventions
- Device: Tack Endovascular System
- 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
- 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
- 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
- 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 below the knee.
- 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)
Michigan Vascular Center
🇺🇸Flint, Michigan, United States
Deborah Heart and Lung Center
🇺🇸Browns Mills, New Jersey, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Kore Cardiovascular Research
🇺🇸Jackson, Tennessee, United States
Division of Angiology, Medical University Graz
🇦🇹Graz, Austria
Karolinen-Hospital
🇩🇪Arnsberg, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Evangelisches Krankenhaus Mülheim an der Ruhr
🇩🇪Mülheim an der Ruhr, Germany
Krankenhaus Buchholz
🇩🇪Nordheide, Germany
Auckland Hospital
🇳🇿Auckland, New Zealand
Rex Hospital
🇺🇸Raleigh, North Carolina, United States
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
WakeMed Hospital
🇺🇸Raleigh, North Carolina, United States
Mission Research Institute
🇺🇸New Braunfels, Texas, United States
St. Anne's University Hospital Brno
🇨🇿Brno, Czechia
Lindner Research Center
🇺🇸Cincinnati, Ohio, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Denver VA Medical Center
🇺🇸Denver, Colorado, United States
Ascension St. John Hospital
🇺🇸Detroit, Michigan, United States
Mission Cardiovascular Research Institute
🇺🇸Fremont, California, United States
Yuma Regional Medical Center
🇺🇸Yuma, Arizona, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
First Coast Cardiovascular Institute
🇺🇸Jacksonville, Florida, United States
Amita Health Cardiovascular Associates
🇺🇸Elk Grove Village, Illinois, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Midwest Cardiovascular Research Foundation
🇺🇸Davenport, Iowa, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
Cardiovascular Institute of the South
🇺🇸Houma, Louisiana, United States
St. Louis Heart & Vascular
🇺🇸Saint Louis, Missouri, United States
Novant Health Heart and Vascular Institute
🇺🇸Matthews, North Carolina, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States
New Mexico Heart Institute, PA
🇺🇸Albuquerque, New Mexico, United States
University Hospitals, Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Einstein Healthcare Network
🇺🇸Philadelphia, Pennsylvania, United States
Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States
Palmetto Health USC Medical Group
🇺🇸Columbia, South Carolina, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas Medical Branch at Galveston
🇺🇸Galveston, Texas, United States
North Dallas Research Associates
🇺🇸McKinney, Texas, United States
Franziskus-Hospital Berlin-Radiology
🇩🇪Berlin, Germany
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Sentara Vascular Specialists
🇺🇸Norfolk, Virginia, United States
Cardiovascular Associates of East Texas
🇺🇸Tyler, Texas, United States
Lake Washington Vascular, PLLC
🇺🇸Bellevue, Washington, United States
Westküstenklinikum Heide
🇩🇪Heide, Germany
MEDINOS Kliniken des Landkreises Sonneberg GmbH
🇩🇪Sonneberg, Germany
Heart & Vascular Center - Semmelweis University
🇭🇺Budapest, Hungary
Bács-Kiskun County Hospital
🇭🇺Kecskemét, Hungary