A Non-Randomized Clinical Study Evaluating Use of the CapBuster Medical Device System for the Crossing of Chronic Total Occlusions

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 13

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
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
>=38.0° 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 <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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Efficacy Endpoint:<br /><br>-Successful crossing of the targeted chronic total occlusion, defined as<br /><br>angiography confirmed guidewire placement in the true lumen without utilization<br /><br>of a re-entry device. The effectiveness endpoint is designed to demonstrate<br /><br>successful crossing of the chronic total occlusion in at least 80% of lesions.<br /><br><br /><br>Primary Safety Endpoints:<br /><br>-Freedom from CapBuster System related clinically significant perforation,<br /><br>embolization, or dissection, defined as perforations or embolization that<br /><br>require intervention and flow-limiting (type C, D, E) dissections.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>I. Study procedure success, defined as successful CTO crossing with the absence<br /><br>of in-hospital/outpatient lab significant events and clinically significant<br /><br>perforation, embolization, or dissection not resolved by visual estimate.<br /><br>II. Evaluation of CTO crossing time.<br /><br>III. Evaluation of total procedural time, fluoroscopic time, and contrast<br /><br>volume.<br /><br>IV. All CapBuster System related adverse events through 30 days post-procedure.<br /><br>V. Lesion treatment success, defined as <= 30% final residual stenosis of the<br /><br>target lesion using commercially available percutaneous treatment modalities.<br /><br>VI. Freedom from CapBuster System related significant events through 30 days,<br /><br>defined as death, unplanned target limb major amputation, and target vessel<br /><br>revascularization that occurred as a result of a CapBuster System related<br /><br>complication or adverse event.</p><br>