Chronic Total Occlusion of Coronary ArteryNCT05733481
Evaluating the Use of the CapBuster System for the Crossing of CTO's in Coronary Arteries
A study testing CapBuster System Medical Device for the Crossing of Chronic Total Occlusions in Coronary Arteries in people with Chronic Total Occlusion of Coronary Artery, run by Praxis Medical Devices Ltd.
Trial summary
Evaluate the safety and effectiveness of the CapBuster System medical device in crossing de novo or restenotic chronic total occlusions in coronary arteries Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion of Coronary Artery
- What is being tested?
- CapBuster System Medical Device for the Crossing of Chronic Total Occlusions in Coronary Arteries
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.).
About this study
Official title: A Non-Randomized Clinical Study Evaluating Use of the CapBuster System Medical Device for the Crossing of Chronic Total Occlusions in Coronary Arteries
Evaluate the safety and effectiveness of the CapBuster System medical device in crossing de novo or restenotic chronic total occlusions in coronary arteries
Read the detailed description
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.
- Being tested
- CapBuster System Medical Device for the Crossing of Chronic Total Occlusions in Coronary Arteries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapBuster System Medical Device for the Crossing of Chronic Total Occlusions in Coronary ArteriesDevice
Also called CapBuster
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CapBuster System Medical Device for the Crossing of Chronic Total Occlusions in Coronary Arteries |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 day follow-up
Secondary outcomes (1)
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
Measured: 30 day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Apr 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total Occlusion of Coronary ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Praxis Medical Devices Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733481
- Sponsor's protocol ID
- CAP002
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not intending to share individual patient data
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized Clinical Study Evaluating Use of the CapBuster System Medical Device for the Crossing of Chronic Total Occlusions in Coronary Arteries
- ClinicalTrials.gov ID
- NCT05733481
- Acronym / sponsor ID
- CAP002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Praxis Medical Devices LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with the presence of coronary arterial de novo or restenotic chronic total occlusion. | Other | Device: CapBuster System Medical Device for the Crossing of Chronic Total Occlusions in Coronary ArteriesSuccessful crossing of the targeted chronic total occlusion, defined as angiography confirmed guidewire placement in the true lumen without utilization of a re-entry device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapBuster System Medical Device for the Crossing of Chronic Total Occlusions in Coronary ArteriesAlso: CapBusterThe 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. | Device | Patients with the presence of coronary arterial de novo or restenotic chronic total occlusion. |
Primary outcome
CTO crossing of the targeted chronic total occlusion
Time frame: 30 day follow-up
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.
CapBuster System related clinically significant events
Time frame: 30 day follow-up
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.
1 secondary outcome
Study procedure
Time frame: 30 day follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No. Not intending to share individual patient data
Related trials for Chronic Total Occlusion of Coronary Artery
Active, not recruiting
To Evaluate Whether IVUS-guided Drug-eluting Stent (DES) Implantation Leads to Better Clinical Outcomes Compared to Conventional Angiography in the Treatment of Chronic Complete Occlusion (CTO) Disease.
Chronic Total Occlusion of Coronary Artery
RecruitingObservational study
Real-World Outcomes of Drug-Coated Balloon Angioplasty in Coronary Artery Disease
Coronary Artery Disease
RecruitingObservational study
Predicting Functional Recovery After Coronary Chronic Total Occlusion Revascularization
Chronic Total Occlusions of Coronary Arteries, Stress Echocardiography (SE)
Not yet recruiting
Drug-Coated Balloon Only Strategy After Recanalization of Chronic Total Coronary Occlusions
Angina (Stable), Coronary Occlusion
RecruitingObservational study
Prospective Global Registry for the Study of Chronic Total Occlusion Intervention
Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CapBuster System Medical Device for the Crossing of Chronic Total Occlusions in Coronary Arteries in people with Chronic Total Occlusion of Coronary Artery, run by Praxis Medical Devices Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTO crossing of the targeted chronic total occlusion (time frame: 30 day follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.