Clinical Study Evaluating Use of the CapBuster Medical Device System for the Crossing of Chronic Total Occlusions

NCT04710342 | Unknown

• 1 other identifier: CAP0001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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 chronic total occlusion. Measures of safety and efficacy will be assessed through 30 days post-intervention.

Conditions

Chronic Total Occlusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• CapBuster system safety from perforations

  12 months

• CapBuster system safety from embolizations

  12 months

• CapBuster system safety from dissections

  12 months

Study Arms (1)

CTO proximal cap crossing

EXPERIMENTAL

To demonstrate that CapBuster breaks the proximal cap of CTO's

Device: CapBuster

Interventions

CapBuster DEVICE

Evaluate the safety and effectiveness of the CapBuster System in crossing de novo or restenotic chronic total occlusions in infrapopliteal peripheral arteries.

CTO proximal cap crossing

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Praxis Medical Devices Ltd: lead
• Ospedale Regionale di Lugano: collaborator
• St. Antonius Hospital: collaborator

Study Sites (1)

St Antonius Ziekenhuis, Koekoekslaan 1, 3435 CM

Nieuwegein, 3435, Netherlands

RECRUITING

Study Officials

• Jihad Mustapha, Dr

  Advanced Cardiac & Vascular Centers for Amputation Prevention Grand Rapids, MI 49525 USA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brendan McLaughlin

CONTACT

353872471662; brendanmclaughlin1@gmail.com

Robert Pendlebury

CONTACT

353831394759; bobpendlebury@gmail.com

Study Design

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

Model Details: If crossing the CTO is not successful with a conventional guidewire, the CapBuster system will be used to try to cross the occlusion

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 14, 2021
• Study Start: June 21, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)