Evaluating the Use of the CapBuster System for the Crossing of CTO's in Coronary Arteries

Study Overview
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Brief Summary
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Evaluate the safety and effectiveness of the CapBuster System medical device in crossing de novo or restenotic chronic total occlusions in coronary arteries

Detailed Description
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Primary Efficacy Endpoints: 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 Endpoints 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 ≤ 30% final residual stenosis of the target lesion using commercially available percutaneous treatment modalities. VI. Freedom from CapBuster System related significant events through 30 days, defined as death or target vessel revascularization that occurred as a result of a CapBuster System related complication or adverse event.

Official Title
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A Non-Randomized Clinical Study Evaluating Use of the CapBuster System Medical Device for the Crossing of Chronic Total Occlusions in Coronary Arteries

Conditions
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Chronic Total Occlusion of Coronary Artery

Intervention / Treatment
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* Device: CapBuster System Medical Device for the Crossing of Chronic Total Occlusions in Coronary Arteries


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males > 18 years of age and Female patients of non child-bearing potential Clinical diagnosis of coronary arterial disease requiring revascularization as evidenced by Duplex UltraSound, Digital Subtraction Angiography, CT angiography, or MR angiography Subject requires single- or multi-vessel percutaneous coronary intervention (PCI) of de novo or restenotic target lesion (including in-stent restenotic lesions). Subject's lesion(s) is (are) amenable to stent treatment with currently available CE or FDA-approved stents. Presence of coronary arterial de novo or restenotic chronic total occlusion (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 Target vessel(s) must be ≥ 2.5 mm and ≤ 3.25 mm in diameter proximal to the target occlusion(s) by visual estimate In the opinion of the investigator, life expectancy of > 1 year Willing and able to sign the informed consent form Exclusion Criteria: Target occlusion is within a bypass graft acute coronary syndrome with ST elevation, cardiogenic shock or out of hospital cardiac arrest 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 Currently participating in another investigational drug or device study Female patients of child-bearing potential. Evidence of STEMI within 72 hours of the intended treatment on infarct related or non-infarct related artery. Cardiogenic shock on presentation or during current hospitalization. Known allergies or contraindication to: contrast materials, antiplatelet therapy, aspirin, clopidogrel (Plavix) and ticlopidine (Ticlid), heparin, bivalirudin, stainless steel, or contrast agent (which cannot be adequately premedicated). Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials). Stroke or transient ischemic attack within the prior 3 months. Any target vessel that has evidence of excessive thrombus (e.g. requires target vessel thrombectomy). Any target vessel that has evidence of excessive tortuousity (greater than 60 degree angle) that makes it unsuitable for proper stent delivery and deployment, Any target lesion that requires treatment with a device other than percutaneous transluminal coronary angioplasty (PTCA) prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with the presence of coronary arterial de novo or restenotic chronic total occlusion.<br>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. | Device: CapBuster System Medical Device for the Crossing of Chronic Total Occlusions in Coronary Arteries<br>* 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 devices. The device system, manufactured by Praxis Medical, comprises the CapBuster support catheter and CapBuster penetrating wire which are mated together with a screw thread.<br>* Other names: CapBuster;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CTO crossing of the targeted chronic total occlusion | 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. | 30 day follow-up | 
| CapBuster System related clinically significant events | 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. | 30 day follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study procedure | 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 caused by use of the CapBuster System | 30 day follow-up |