Status:
UNKNOWN
Clinical Study Evaluating Use of the CapBuster Medical Device System for the Crossing of Chronic Total Occlusions
Lead Sponsor:
Praxis Medical Devices Ltd
Collaborating Sponsors:
Ospedale Regionale di Lugano
St. Antonius Hospital
Conditions:
Chronic Total Occlusion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 chro...
Detailed Description
The diagnostic and interventional procedure can be conducted via contralateral or antegrade approach and arterial access will be obtained utilizing standard percutaneous techniques and devices. Baseli...
Eligibility Criteria
Inclusion
- Males \> 18 years of age and Female patients of non child-bearing potential
- Clinical diagnosis of peripheral arterial disease requiring revascularization as evidenced by Duplex UltraSound, Digital Subtraction Angiography, CT angiography, or MR angiography
- Rutherford Classification 2-5
- 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
- Target vessel(s) must be ≥ 2.5 mm and ≤ 3.25 mm in diameter proximal to the target occlusion(s) by visual estimate
- Target occlusions(s) cannot be crossed by conventional guidewire (crossing time limited to ≤5 minutes)
- In the opinion of the investigator, life expectancy of \> 1 year
- Willing and able to sign the informed consent form
Exclusion
- Target occlusion is within a bypass graft
- Target occlusion can be crossed by conventional guidewire
- Target occlusion is below tibiotalar joint
- Presence of acute limb ischemia
- Known sensitivity or allergy to contrast materials that cannot be adequately pre-treated
- Known allergy or contraindication to all antiplatelet therapy
- 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.
- Known or suspected myocardial infarction or stroke within previous 30 days
- Significant acute or chronic renal disease with a GFR \<30 mL/min/1.73m2
- 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
- Planned surgical or endovascular procedure prior to the subject's 30-day follow-up. Planned minor amputations are allowed.
- Subject is scheduled for a target limb major amputation (above the ankle) within 30 days post study procedure
- Currently participating in another investigational drug or device study
- Unwilling or unable to comply with the protocol or follow-up requirements
- 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
- Female patients of child-bearing potential.
Key Trial Info
Start Date :
June 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04710342
Start Date
June 21 2021
End Date
December 31 2023
Last Update
February 21 2023
Active Locations (1)
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1
St Antonius Ziekenhuis, Koekoekslaan 1, 3435 CM
Nieuwegein, Netherlands, 3435