The ABSORB BTK (Below The Knee) Clinical Investigation
NCT01341340 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2019-04-11
Summary
The purpose of the ABSORB BTK Clinical Investigation is to evaluate the safety and efficacy of the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS) in subjects with critical limb ischemia (CLI) following percutaneous transluminal angioplasty (PTA) of the tibial arteries.
Conditions
- Atherosclerosis
- Peripheral Artery Disease
- Peripheral Vascular Disease
- PAD
- Claudication
- Critical Limb Ischemia
- Lower Limb Disease
- Peripheral Arterial Occlusive Disease
- PAOD
- PVD
Interventions
- DEVICE
-
Everolimus Eluting BVS
Patients receiving the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS)
Sponsors & Collaborators
-
Abbott Medical Devices
lead INDUSTRY
Principal Investigators
-
Dierk Scheinert, MD · Herz-Zentrum Leipzig
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-11-30
- Primary Completion
- 2012-11-30
- Completion
- 2012-11-30
Countries
- Belgium
Study Locations
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