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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.
Verified September 2017 by Intact Vascular
Sponsor:
ClinicalTrials.gov Identifier:
NCT02942966
First Posted: October 24, 2016
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Intact Vascular
  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: None (Open Label)
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 6 months [ Time Frame: 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)

  • 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: 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 [ Time Frame: 6 months ]
    Target Limb Salvage defined as freedom from any above-ankle target limb amputation at 6 months.


Estimated Enrollment: 232
Actual Study Start Date: February 8, 2017
Estimated Study Completion Date: October 2022
Estimated Primary Completion Date: December 2019 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02942966


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

  Show 22 Study Locations
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
First Submitted: October 20, 2016
First Posted: October 24, 2016
Last Update Posted: September 20, 2017
Last Verified: September 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