Peripheral Artery Disease Clinical Trial
— TOBA IIOfficial title:
Tack Optimized Balloon Angioplasty Study for Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System™
NCT number | NCT02522884 |
Other study ID # | CA 0119 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | March 2020 |
Verified date | April 2021 |
Source | Philips Clinical & Medical Affairs Global |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 213 |
Est. completion date | March 2020 |
Est. primary completion date | May 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subject must meet all of the following inclusion criteria to be eligible for enrollment: 1. Male or non-pregnant Female = 18 years of age at the time of consent 2. 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) 3. Target limb requires no additional treatment aside from the target lesion and the iliac artery(ies) during the index procedure 4. 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 5. Willing to comply with all required follow-up visits 6. Rutherford Classification 2, 3 or 4 7. Estimated life expectancy >1 year 8. Eligible for standard surgical repair, if necessary 9. 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: 1. Rutherford Classification 0, 1, 5 or 6 2. Is pregnant or refuses to use contraception through the duration of the study 3. Previous infrainguinal bypass graft in the target limb 4. Planned amputation on the target limb 5. Systemic infection or Infection within the target limb and/or immunocompromised 6. 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 7. 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 8. 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 9. Any other previous or planned surgical or endovascular procedure (not including diagnostic procedures) within 14 days prior to or 30 days post index procedure 10. 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 11. Known coagulopathy, hypercoagulable state, bleeding diathesis, other blood disorder, or a platelet count less than 80,000/microliter or greater than 500,000/microliter 12. Known hypersensitivity or allergy to antiplatelet or anticoagulant therapy 13. Myocardial infarction within 30 days prior to enrollment 14. History of stroke within 90 days prior to enrollment 15. Serum creatinine of >2.5 mg/dL 16. 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 17. Known hypersensitivity or contraindication to nickel-titanium alloy (Nitinol) 18. Participating in another ongoing investigational clinical trial that has not completed its primary endpoint 19. 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 20. Known hypersensitivity or allergy to contrast agents that cannot be medically managed 21. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University Hospital Graz | Graz | |
Austria | Hanusch Krankenhaus | Vienna | |
Netherlands | St. Antonius Hospital | Nieuwegein | Utrecht |
United States | New Mexico Heart Institute, PA | Albuquerque | New Mexico |
United States | Cedars Sinai Medical Center | Beverly Hills | California |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Holy Spirit Cardiology | Camp Hill | Pennsylvania |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Ohio Health Research Institute | Columbus | Ohio |
United States | Midwest Cardiovascular Research Foundation | Davenport | Iowa |
United States | Denver VA Medical Center | Denver | Colorado |
United States | Alexian Brothers Medical Center Heart & Vascular Institute | Elk Grove Village | Illinois |
United States | Mission Cardiovascular Research Institute | Fremont | California |
United States | Florida Research Network, LLC | Gainesville | Florida |
United States | Baylor College of Medicine | Houston | Texas |
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
United States | University of Iowa | Iowa City | Iowa |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | Wellmont CVA Heart Institute | Kingsport | Tennessee |
United States | Adventist Midwest Health | LaGrange | Illinois |
United States | St. Mary Medical Center | Langhorne | Pennsylvania |
United States | Central Arkansas Veteran's Healthcare System | Little Rock | Arkansas |
United States | North Dallas Research Associates | McKinney | Texas |
United States | Mission Research Institute | New Braunfels | Texas |
United States | Yale New Haven Hospital | New Haven | Connecticut |
United States | Sentara Vascular Specialists | Norfolk | Virginia |
United States | St. Joseph Hospital | Orange | California |
United States | Einstein Medical Center Philadelphia | Philadelphia | Pennsylvania |
United States | The Miriam Hospital | Providence | Rhode Island |
United States | NC Heart and Vascular Research | Raleigh | North Carolina |
United States | NC Heart and Vascular Research - WakeMed Raleigh | Raleigh | North Carolina |
United States | North Central Heart | Sioux Falls | South Dakota |
United States | Prairie Education and Research Cooperative | Springfield | Illinois |
United States | Holy Name Medical Center | Teaneck | New Jersey |
United States | MedStar Washington Hospital Center | Washington | District of Columbia |
United States | Pinnacle Health Cardiovascular Institute | Wormleysburg | Pennsylvania |
United States | Lankenau Medical Center | Wynnewood | Pennsylvania |
United States | Metro Health Hospital | Wyoming | Michigan |
United States | Yuma Regional Medical Center | Yuma | Arizona |
Lead Sponsor | Collaborator |
---|---|
Philips Clinical & Medical Affairs Global |
United States, Austria, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy - Number of Subjects That Met Primary Patency Criteria at 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) | 12 Months | |
Primary | Safety - Number of Subjects That Met the Primary Safety Criteria of Freedom From Major Adverse Events at 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. | 30 Days |
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