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

NCT02235675 | Completed DMC

• 1 other identifier: TD 0109
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Limb Ischemia; Peripheral Artery Disease

Keywords

Angioplasty; Peripheral Artery Disease; Critical Limb Ischemia; CLI; PAD

Outcome Measures

Primary Outcomes (1)

• 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

  30 Days

Secondary Outcomes (1)

• Secondary Endpoints

  1, 3, 6 and 12 Months

Other Outcomes (1)

• Observational Endpoint

  6 Months

Study Arms (1)

Tack-It

EXPERIMENTAL

Implant of the Intact Vascular Tack-It Endovascular System to repair post angioplasty dissections.

Device: Tack-It Endovascular System

Interventions

Tack-It Endovascular System DEVICE

Repair of post-PTA dissections using the Intact Vascular Tack-It implant.

Also known as: Tack-It Dissection Repair, Intact Vascular Tack-It, Tack-It, Tack

Tack-It

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (1)

Medizinische Universitat Graz

Graz, A-8036, Austria

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Marianne Brodmann, MD

  MEDIZINISCHE UNIVERSITAT GRAZ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 10, 2014
• Study Start: December 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2017
• Last Updated: April 5, 2021

Record last verified: 2021-04

Locations

AU (1)