NL-OMON51946
Recruiting
N/A
A Non-Randomized Clinical Study Evaluating Use of the CapBuster Medical Device System for the Crossing of Chronic Total Occlusions - CapBuster
Praxis Medical Devices Ltd.0 sites13 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Praxis Medical Devices Ltd.
- Enrollment
- 13
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Males \> 18 years of age and Female patients of non child\-bearing potential
- •2\. Clinical diagnosis of peripheral arterial disease requiring
- •revascularization as evidenced by contrast, CT, or MR angiography
- •3\. Rutherford Classification 2\-5
- •4\. Presence of infrapopliteal arterial de novo or restenotic chronic total
- •occlusion(s) (100% stenosis), with TIMI 0 flow, confirmed by angiography.
- •Vessel distal to the occlusion(s) must be visualized per collateral or
- •retrograde flow. A maximum of 1 target occlusions can be treated per patient.
- •Target occlusion(s) can be in\-stent restenosis
- •5\. Target vessel(s) must be \>\= 2\.5 mm and \<\= 3\.25 mm in diameter proximal to the
Exclusion Criteria
- •1\. Target occlusion is within a bypass graft
- •2\. Target occlusion can be crossed by conventional guidewire
- •3\. Target occlusion is below tibiotalar joint
- •4\. Presence of acute limb ischemia
- •5\. Known sensitivity or allergy to contrast materials that cannot be adequately
- •pre\-treated
- •6\. Known allergy or contraindication to all antiplatelet therapy
- •7\. Subject has signs or symptoms of systemic infection/sepsis (temperature
- •\>\=38\.0° Celsius and WBC \>\=12,000 cells/uL). If subject has localized infection,
- •including cellulitis or osteomyelitis, or infection is adequately treated and
Outcomes
Primary Outcomes
Not specified
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