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Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries (TOBA II BTK)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Intact Vascular
Sponsor:
Information provided by (Responsible Party):
Intact Vascular
ClinicalTrials.gov Identifier:
NCT02942966
First received: October 20, 2016
Last updated: June 20, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention
Peripheral Arterial Disease Device: Tack Endovascular System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Tack Optimized Balloon Angioplasty Study for the Below The Knee Arteries Using the Tack Endovascular System®

Resource links provided by NLM:


Further study details as provided by Intact Vascular:

Primary Outcome Measures:
  • Efficacy - Freedom from MALE at 12 months [ Time Frame: 12 months ]
    Freedom from major adverse limb events (MALE) at 12 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)

  • Efficacy - Freedom from POD at 30 days [ Time Frame: 30 days ]
    Freedom from perioperative death (POD) at 30 days

  • Safety - Freedom from MALE at 30 days [ Time Frame: 30 days ]
    Freedom from 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)

  • Safety - Freedom from POD at 30 days [ Time Frame: 30 days ]
    Freedom from perioperative death (POD) at 30 days


Secondary Outcome Measures:
  • Patency [ Time Frame: 12 months ]
    Target lesion(s) tacked segment(s) patency at 12 months defined as the presence of blood flow using duplex ultrasound. If angiography is available within the 12 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 [ Time Frame: 12 months ]
    Target Limb Salvage defined as freedom from any above-ankle target limb amputation at 12 months.


Estimated Enrollment: 232
Actual Study Start Date: February 8, 2017
Estimated Study Completion Date: October 2022
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tack Implant
Implantation of a Tack using the Intact Vascular Tack Endovascular System for the repair of post angioplasty dissections below the knee.
Device: Tack Endovascular System
Repair of post-PTA dissections using the Intact Vascular Tack Endovascular System.
Other Names:
  • Post-PTA Dissection Repair Implant
  • Tack Implant
  • Tack Dissection Repair Device

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 3, 4 or 5. Rutherford 5 subjects may not exceed the following WIfI scores: Wound 0, 1 or modified 2, Ischemia 0-3, Infection 0-1. To further specify, the "modified 2" Wound Grade permits a deeper ulcer without exposed bone, joint or tendon; or shallow or superficial heel ulcer, without deep tissue involvement or exposed calcaneus. It also permits gangrenous changes limited to digits.
  • Estimated life expectancy ≥1 year

Exclusion Criteria:

  • Is pregnant or refuses to use contraception through the duration of the study
  • Previous infrainguinal 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 to the target limb, including transmetatarsal amputation and full thickness heel gangrene (this does not apply to digital amputations or ulcer debridements)
  • Infection that exceeds WIfI grade 0 or 1. This includes 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 are excluded from participation
  • Endovascular or surgical procedure (not including diagnostic procedures or planned digit amputation/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 and/or in-stent restenosis of target lesion
  • Endovascular or surgical procedure (not including diagnostic procedures) to the non-target limb less than 14 days prior to the index procedure or planned procedure less than 30 days after the index procedure
  • Any other endovascular or surgical procedure (not including diagnostic procedures) less than 14 days prior to the index procedure or planned procedure less than 30 days after the index procedure
  • Use of atherectomy, cryoplasty, cutting/scoring/contoured balloon angioplasty, stenting or any other treatment (with the exception of a crossing device) of the target lesion other than plain balloon angioplasty 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
  • Wound(s) that exceed WIfI grade 0, 1, or Modified 2. The "Modified 2" grade permits a deeper ulcer without exposed bone, joint or tendon; or shallow or superficial heel ulcer, without deep tissue involvement or exposed calcaneus. It also permits gangrenous changes limited to digits.
  • Any subject in which antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated
  • Myocardial infarction, 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02942966

Contacts
Contact: Joseph C Griffin, III 484-253-1043 jgriffin@intactvascular.com

Locations
United States, Arizona
Yuma Regional Medical Center Recruiting
Yuma, Arizona, United States, 85364
Contact: Joseph A. Cardenas, MD    928-341-9522      
Contact: Yesenia Zambrano    928-336-3364      
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, D.C., District of Columbia, United States, 20010
Contact: Nelson Bernardo, MD    202-877-5975      
Contact: Kassaye Sesabe    202-877-7452      
United States, Illinois
Prairie Education & Research Cooperative Recruiting
Springfield, Illinois, United States, 62701
Contact: Jeffrey Goldstein, MD    217-492-9100      
Contact: Katie Mottershaw    217-492-9100      
United States, Iowa
Midwest Cardiovascular Research Foundation Recruiting
Davenport, Iowa, United States, 52803
Contact: Nicolas Shammas, MD    563-320-0263      
Contact: Holly Park    563-324-2828      
United States, Louisiana
Cardiovascular Institute of the South Recruiting
Houma, Louisiana, United States, 70360
Contact: Craig M. Walker, MD    985-876-0300      
Contact: Deanna Benoit    985-873-5613      
United States, Michigan
Michigan Vascular Center Recruiting
Flint, Michigan, United States, 48507
Contact: Robert Molnar, MD    810-600-2009      
Contact: Maureen Blewett    810-600-2009      
United States, Texas
North Dallas Research Associates Recruiting
McKinney, Texas, United States, 75069
Contact: Muhammad Khan, MD    972-562-2345      
Contact: Irfan Ullah    972-562-2345      
Sponsors and Collaborators
Intact Vascular
Investigators
Principal Investigator: Patrick J. Geraghty, MD Washington University School of Medicine in St. Louis
Principal Investigator: George Adams, MD Rex Hospital
  More Information

Publications:
Responsible Party: Intact Vascular
ClinicalTrials.gov Identifier: NCT02942966     History of Changes
Other Study ID Numbers: CA 0137
Study First Received: October 20, 2016
Last Updated: June 20, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Intact Vascular:
Angioplasty
Below the Knee
PAD
Critical Limb Ischemia
Lesion
Claudication

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 26, 2017