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

NCT05733481 | Unknown DMC

• 1 other identifier: CAP002
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Total Occlusion of Coronary Artery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Study procedure

  30 day follow-up

Study Arms (1)

Patients with the presence of coronary arterial de novo or restenotic chronic total occlusion.

OTHER

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

Interventions

CapBuster System Medical Device for the Crossing of Chronic Total Occlusions in Coronary Arteries DEVICE

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.

Also known as: CapBuster

Patients with the presence of coronary arterial de novo or restenotic chronic total occlusion.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Praxis Medical Devices Ltd: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 17, 2023
• Study Start: April 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share