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

Primary Purpose

Critical Limb Ischemia, Peripheral Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Tack-It Endovascular System
Sponsored by
Philips Clinical & Medical Affairs Global
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Limb Ischemia focused on measuring Angioplasty, Peripheral Artery Disease, Critical Limb Ischemia, CLI, PAD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medizinische Universitat Graz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tack-It

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Secondary Endpoints
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)

Full Information

First Posted
September 4, 2014
Last Updated
April 2, 2021
Sponsor
Philips Clinical & Medical Affairs Global
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1. Study Identification

Unique Protocol Identification Number
NCT02235675
Brief Title
Tack Optimized Balloon Angioplasty Below the Knee (TOBA - BTK) Study
Acronym
TOBABTK
Official Title
Prospective, Multicenter Tack Optimized Balloon Angioplasty Below the Knee (TOBA - BTK) Study for Infrapopliteal Arteries Using the Tack-It Endovascular System™
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Clinical & Medical Affairs Global

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia, Peripheral Artery Disease
Keywords
Angioplasty, Peripheral Artery Disease, Critical Limb Ischemia, CLI, PAD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tack-It
Arm Type
Experimental
Arm Description
Implant of the Intact Vascular Tack-It Endovascular System to repair post angioplasty dissections.
Intervention Type
Device
Intervention Name(s)
Tack-It Endovascular System
Other Intervention Name(s)
Tack-It Dissection Repair, Intact Vascular Tack-It, Tack-It, Tack
Intervention Description
Repair of post-PTA dissections using the Intact Vascular Tack-It implant.
Primary Outcome Measure Information:
Title
Primary Endpoints
Description
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
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Secondary Endpoints
Description
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)
Time Frame
1, 3, 6 and 12 Months
Other Pre-specified Outcome Measures:
Title
Observational Endpoint
Description
The following parameter will be assessed at 6 months (Per local Standard of Care): • Angiographic percent diameter stenosis
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Brodmann, MD
Organizational Affiliation
MEDIZINISCHE UNIVERSITAT GRAZ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Universitat Graz
City
Graz
ZIP/Postal Code
A-8036
Country
Austria

12. IPD Sharing Statement

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

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