peripheral atherosclerosis peripheral vascular disease
Conditions
Interventions
The CapBuster System is a medical device intended to facilitate the
intraluminal placement of conventional guidewires beyond chronic total
occlusions prior to the utilization of interventional devic
Sponsors
Praxis Medical Devices Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion 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 1 year 8. Willing and able to sign the informed consent form
Exclusion criteria
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 controlled, per investigator discretion, patient may be enrolled. 8. Known or suspected myocardial infarction or stroke within previous 30 days 9. Significant acute or chronic renal disease with a GFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Endpoint: -Successful crossing of the targeted chronic total occlusion, defined as angiography confirmed guidewire placement in the true lumen without utilization of a re-entry device. The effectiveness endpoint is designed to demonstrate successful crossing of the chronic total occlusion in at least 80% of lesions. Primary Safety Endpoints: -Freedom from CapBuster System related clinically significant perforation, embolization, or dissection, defined as perforations or embolization that require intervention and flow-limiting (type C, D, E) dissections. | — |
Secondary
| Measure | Time frame |
|---|---|
| I. Study procedure success, defined as successful CTO crossing with the absence of in-hospital/outpatient lab significant events and clinically significant perforation, embolization, or dissection not resolved by visual estimate. II. Evaluation of CTO crossing time. III. Evaluation of total procedural time, fluoroscopic time, and contrast volume. IV. All CapBuster System related adverse events through 30 days post-procedure. V. Lesion treatment success, defined as | — |
Countries
Netherlands
Outcome results
None listed