Clinical trial NCT02522884: Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries
Official title: Tack Optimized Balloon Angioplasty Study for Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: Angioplasty
Peripheral Artery Disease
PAD
Lesion
Claudication
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2015-08-13
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy - Number of Subjects That Met Primary Patency Criteria at 12 Months
timeFrame: 12 Months
measure: Safety - Number of Subjects That Met the Primary Safety Criteria of Freedom From Major Adverse Events at 30 Days
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Yuma
country: United States
facility: Yuma Regional Medical Center
state: Arizona
city: Little Rock
country: United States
facility: Central Arkansas Veteran's Healthcare System
state: Arkansas
city: Beverly Hills
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Fremont
country: United States
facility: Mission Cardiovascular Research Institute
state: California
city: Orange
country: United States
facility: St. Joseph Hospital
state: California
city: Denver
country: United States
facility: Denver VA Medical Center
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Gainesville
country: United States
facility: Florida Research Network, LLC
state: Florida
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center Heart & Vascular Institute
state: Illinois
city: LaGrange
country: United States
facility: Adventist Midwest Health
state: Illinois
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Wyoming
country: United States
facility: Metro Health Hospital
state: Michigan
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute, PA
state: New Mexico
city: Raleigh
country: United States
facility: NC Heart and Vascular Research
state: North Carolina
city: Raleigh
country: United States
facility: NC Heart and Vascular Research - WakeMed Raleigh
state: North Carolina
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Camp Hill
country: United States
facility: Holy Spirit Cardiology
state: Pennsylvania
city: Langhorne
country: United States
facility: St. Mary Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Einstein Medical Center Philadelphia
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health Cardiovascular Institute
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Sioux Falls
country: United States
facility: North Central Heart
state: South Dakota
city: Kingsport
country: United States
facility: Wellmont CVA Heart Institute
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: McKinney
country: United States
facility: North Dallas Research Associates
state: Texas
city: New Braunfels
country: United States
facility: Mission Research Institute
state: Texas
city: Norfolk
country: United States
facility: Sentara Vascular Specialists
state: Virginia
city: Graz
country: Austria
facility: Medical University Hospital Graz
city: Vienna
country: Austria
facility: Hanusch Krankenhaus
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
state: Utrecht
Study officials:
affiliation: Main Line Health/Lankenau Heart Institute
name: William A. Gray, MD
role: PRINCIPAL_INVESTIGATOR
References: