Safety and effectiveness of ByCross Rotational and Aspiration device for revascularization of total or sub-total occluded peripheral arterial vessels of luminal diameter equal to or larger than 3mm: A prospective, multi-center study
- Conditions
- I70.2I74.3Atherosclerosis of arteries of extremitiesEmbolism and thrombosis of arteries of lower extremities
- Registration Number
- DRKS00015758
- Lead Sponsor
- Taryag-Medical Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 42
1. Subject has documented symptomatic (Rutherford 2-6), chronic peripheral vascular disease requiring percutaneous intervention and are indicated for atherectomy at superficial femoral (SFA) and/or popliteal artery and/or tibioperoneal trunk (TPT).
2. Target lesion is at least 10mm distal to the SFA origin and at least 10mm proximal to the distal end of the TPT.
3. Total or sub-total occlusion of target vessel (stenosis =80%)
4. Vessel lumen =3.0mm
5. Lesion length =3.0cm
6. Subject has been informed on the nature of the study and is willing and able to provide informed consent
7. Subject is capable of meeting study requirements including presences at follow-up visits
1. Subject is unable to take antiplatelet drugs
2. Vessel of the cardiopulmonary, coronary or cerebral circulation
3. Subject has anticipated life expectance < 12 month
4. Subject is diagnosed with impaired renal function (creatinine >2.5 mg/dL)
5. Subject has undergone or planned surgical or endovascular procedure 15 days before or after the study procedure
6. Vessel lumen <3.0mm
7. Stent at access and target vessel or In-stent restenosis at target lesion
8. Target and/or access vessel include by-pass graft
9. Target vessel is dissected
10. Target is at vessel segment which includes tortuous course with radius of curvature <= 40mm
11. Access pathway includes tortuous course with radius of curvature <= 25mm
12. Target and/or access vessel includes aneurysm altered segments
13. Persistent vasospasm
14. Known or suspected allergy to any of the components of the sys-tem or to a medicinal product to be administered in connection with the planned procedure
15. Subject is pregnant or planning to become pregnant within the study period, or lactating mothers
16. Subject is enrolled to another clinical investigation that might interfere with this study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Rate of subjects with post atherectomy stenosis = 50% and post procedure stenosis = 30%, Time Frame: Up to 8 hours post-procedure.<br>2. Rate of major adverse events, Time Frame: 30-days follow-up.
- Secondary Outcome Measures
Name Time Method 1. Stenosis level, Time Frame: up to 96 hours, 30-days and 6-months follow-up.<br>2. Ankle Brachial Pressure Index, Time Frame: up to 96 hours, 30-days and 6 months follow-up<br>3. Major adverse events, Time Frame: Up to 8 hours post-procedure, up to 96 hours, 6-months follow-up, and 12-months if applicable.