Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    TOBA BTK
Previous Study | Return to List | Next Study

Tack Optimized Balloon Angioplasty Below the Knee (TOBA - BTK) Study (TOBABTK)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02235675
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
Intact Vascular

Brief Summary:
Multi-center study to optimize below the knee (BTK) balloon angioplasty results by creating tissue apposition in peripheral arteries with Reference Vessel Diameter's (RVD) ranging from 1.5mm to 4.5mm.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Peripheral Artery Disease Device: Tack-It Endovascular System Not Applicable

Detailed Description:

This first in man (FIM) study is to collect data in support of the safety and performance of the Intact Vascular Tack-It Endovascular System™ for tissue apposition to optimize balloon angioplasty.

Study primary endpoints:

Safety: Composite of Major Adverse Limb Events (MALE) and Peri-procedural Death (POD), assessed at 1 month. Endpoint includes any of the following:

  • Major amputation - amputation above the ankle
  • Re-intervention (surgical or endovascular) in the target limb
  • Procedure-related death - any death within 1 month of the index procedure or any MALE

Device Success: The achievement of successful delivery and deployment of the study device(s) at the intended target site(s) and successful withdrawal of the delivery catheter.

Technical Success: Device success (defined above) and the ability of the Tack to resolve post-PTA dissection, demonstrating angiographic patency at the conclusion of the procedure.

Clinical Success: Ability of the Tack to resolve post-PTA dissection and achieve patency at the conclusion of the procedure, without procedure related complications within 48 hours after the index procedure or at hospital discharge, whichever is sooner.

Study secondary endpoints:

The following events will be assessed at 3, 6 and 12 months:

  • All-cause mortality
  • Amputation of the limb (above the ankle)
  • Amputation free survival
  • Clinically driven target vessel revascularization (TVR)
  • Clinically driven target lesion revascularization (TLR)
  • Changes in Rutherford Clinical Category from baseline

The following parameters will be assessed at 1, 3, 6 and 12 months:

  • Maintenance of luminal patency of the target lesion by TBI (≤0.15 decrease) as compared to the baseline TBI obtained prior to discharge
  • Doppler Exam (presence of signal)

Study observational endpoint:

The following parameter will be assessed at 6 months (Per local Standard of Care):

• Angiographic percent diameter stenosis


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Multicenter Tack Optimized Balloon Angioplasty Below the Knee (TOBA - BTK) Study for Infrapopliteal Arteries Using the Tack-It Endovascular System™
Study Start Date : December 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Experimental: Tack-It
Implant of the Intact Vascular Tack-It Endovascular System to repair post angioplasty dissections.
Device: Tack-It Endovascular System
Repair of post-PTA dissections using the Intact Vascular Tack-It implant.
Other Names:
  • Tack-It Dissection Repair
  • Intact Vascular Tack-It
  • Tack-It
  • Tack




Primary Outcome Measures :
  1. Primary Endpoints [ Time Frame: 30 Days ]

    Safety: Composite of Major Adverse Limb Events (MALE) and Peri-procedural Death (POD), assessed at 1 month. Endpoint includes any of the following:

    • Major amputation - amputation above the ankle
    • Re-intervention (surgical or endovascular) in the target limb
    • Procedure-related death - any death within 1 month of the index procedure or any MALE


Secondary Outcome Measures :
  1. Secondary Endpoints [ Time Frame: 1, 3, 6 and 12 Months ]

    The composite of following events will be assessed at 3, 6 and 12 months or as noted:

    • All-cause mortality
    • Amputation of the limb (above the ankle)
    • Amputation free survival
    • Clinically driven target vessel revascularization (TVR)
    • Clinically driven target lesion revascularization (TLR)
    • Changes in Rutherford Clinical Category from baseline
    • Maintenance of luminal patency of the target lesion by TBI (≤0.15 decrease) as compared to the baseline TBI obtained prior to discharge at 1,3,6 and 12 months.
    • Doppler Exam (presence of signal at 1,3,6 and 12 months)


Other Outcome Measures:
  1. Observational Endpoint [ Time Frame: 6 Months ]

    The following parameter will be assessed at 6 months (Per local Standard of Care):

    • Angiographic percent diameter stenosis




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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age of subject is >18
  • Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the consent form
  • Subject has critical limb ischemia (CLI)
  • Subject has Rutherford Clinical Category 4-5. (hemodynamic reference)
  • Reference vessel diameter below the knee (BTK) is between 1.5mm and 4.5mm (inclusive).
  • De-novo target lesion(s) has stenosis >70%.
  • Must be able to perform PTA. The PTA must result in a dissection Type A - F at some location along the treatment site.
  • Any vessel intervened on must have distal reconstitution above the ankle.
  • Inflow Iliac, SFA and Popliteal lesions can be treated during the same procedure using standard angioplasty and/or an approved device. These inflow lesions must be treated first, prior to consideration of treatment of BTK lesions. The patient can be enrolled if the inflow lesions are treated with good angiographic results (must have <30% residual stenosis and no evidence of embolization).

Key Exclusion Criteria:

  • The subject has a lesion on the plantar surface of the heel or over the Achilles tendon or has exposed calcaneus.
  • The subject has extensive forefoot gangrene / ischemic ulcer that cannot be resolved with standard metatarsal amputation.
  • Previous treatment failure of inflow arteries (Iliac, SFA and Popliteal)
  • Subject with below knee bypass.
  • Subject has significant stenosis or occlusion of inflow vessels tract (proximal disease) not successfully treated (>30% residual stenosis and/or complication of the procedure) prior to BTK angioplasty and patient enrollment.
  • Subject is permanently wheel-chair bound or bedridden.
  • Subject has an allergy to contrast medium that cannot be pretreated.
  • Episode of acute limb ischemia within the previous 30 days.
  • Subject is undergoing atherectomy in the target limb or cryoplasty or stenting of BTK treatment site.
  • Subject has a systemic infection with positive blood cultures/bacteremia within one week.
  • Subject has undrained pus or spreading wet gangrene in the foot that is not controlled at the time of revascularization procedure.
  • Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
  • Myocardial infarction within 30 days prior to enrollment.
  • History of stroke within 180 days prior to enrollment.
  • Subject has acute or chronic renal disease (e.g., as measured by a serum creatinine of >2.5 mg/dL or >220 umol/L).
  • Subject has a known hypersensitivity or contraindication to nitinol.

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): NCT02235675


Locations
Layout table for location information
Austria
Medizinische Universitat Graz
Graz, Austria, A-8036
Sponsors and Collaborators
Intact Vascular
Investigators
Layout table for investigator information
Principal Investigator: Marianne Brodmann, MD MEDIZINISCHE UNIVERSITAT GRAZ

Layout table for additonal information
Responsible Party: Intact Vascular
ClinicalTrials.gov Identifier: NCT02235675     History of Changes
Other Study ID Numbers: TD 0109
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: March 2017

Keywords provided by Intact Vascular:
Angioplasty
Peripheral Artery Disease
Critical Limb Ischemia
CLI
PAD

Additional relevant MeSH terms:
Layout table for MeSH terms
Ischemia
Peripheral Arterial Disease
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases