Chronic Total Occlusion Clinical Trial
— CapBusterOfficial title:
A Non-Randomized Clinical Study Evaluating Use of the CapBuster Medical Device System for the Crossing of Chronic Total Occlusions
This study represents a prospective, non-randomized, dual-center clinical study to evaluate the safety and effectiveness of the CapBuster System in crossing a de novo or restenotic infrapopliteal chronic total occlusion. Measures of safety and efficacy will be assessed through 30 days post-intervention.
Status | Recruiting |
Enrollment | 26 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 Duplex UltraSound, Digital Subtraction Angiography, CT angiography, 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 2 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 target occlusion(s) by visual estimate 6. Target occlusions(s) cannot be crossed by conventional guidewire (crossing time limited to =5 minutes) 7. In the opinion of the investigator, life expectancy of > 1 year 8. Willing and able to sign the informed consent form 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 =38.0o 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 <30 mL/min/1.73m2 10. History of a surgical or endovascular procedure on the target limb within 30 days of the index procedure or non-target limb within 2 weeks of the index procedure 11. Planned surgical or endovascular procedure prior to the subject's 30-day follow-up. Planned minor amputations are allowed. 12. Subject is scheduled for a target limb major amputation (above the ankle) within 30 days post study procedure 13. Currently participating in another investigational drug or device study 14. Unwilling or unable to comply with the protocol or follow-up requirements 15. Any concurrent medical, psychological, or social condition, which may significantly interfere with the subject's optimal participation in the study, in the opinion of the investigator 16. Female patients of child-bearing potential. |
Country | Name | City | State |
---|---|---|---|
Netherlands | St Antonius Ziekenhuis, Koekoekslaan 1, 3435 CM | Nieuwegein |
Lead Sponsor | Collaborator |
---|---|
Praxis Medical Devices Ltd | Ospedale Regionale di Lugano, St. Antonius Hospital |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CTO Crossing | 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. | 12 months | |
Secondary | CapBuster system safety from perforations | Freedom from CapBuster System related clinically significant perforations that require intervention | 12 months | |
Secondary | CapBuster system safety from embolizations | Freedom from CapBuster System related clinically significant embolizations that require intervention | 12 months | |
Secondary | CapBuster system safety from dissections | Freedom from CapBuster System related clinically significant flow-limiting (type C, D, E) dissections that require intervention. | 12 months |
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