Chronic Total OcclusionCapBusterNCT04710342
Clinical Study Evaluating Use of the CapBuster Medical Device System for the Crossing of Chronic Total Occlusions
A study testing CapBuster in people with Chronic Total Occlusion, run by Praxis Medical Devices Ltd at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion
- What is being tested?
- CapBuster
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Jun 2021to 31 Dec 2023
- 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 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
Who cannot join
- 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
Show all 16Show fewer
- 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
- Female patients of child-bearing potential.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
St Antonius Ziekenhuis, Koekoekslaan 1, 3435 CM
Nieuwegein, 3435
Daniel van den Heuvel, yes, 31646216968, d.van.den.heuvel@antoniusziekenhuis.nl
About this study
Official title: A Non-Randomized Clinical Study Evaluating Use of the CapBuster Medical Device System for the Crossing of Chronic Total Occlusions
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.
Read the detailed description
The diagnostic and interventional procedure can be conducted via contralateral or antegrade approach and arterial access will be obtained utilizing standard percutaneous techniques and devices. Baseline angiographic images will be obtained prior to the study intervention to confirm the presence of a peripheral arterial occlusion. These images will include the target lesion as well as inflow and outflow with ipsilateral run off to the distal foot. If angiographic imaging confirms that the subject meets enrollment criteria, the enrolled subject will then undergo the study procedure.
If the investigator determines that treatment is required of non-target arterial lesions, the treatment may be performed during the study index procedure according to the investigator's standard practices using commercially available devices.
Prior to utilization of the CapBuster system, the investigator will attempt to cross the target lesion CTO utilizing conventional catheters and guidewires. To minimize vessel trauma, attempted guidewire crossing time will be limited to no more than 5 minutes. The crossing time will begin when the guidewire reaches the lesion CTO cap and will end after occlusion is successfully crossed with confirmed wire placement in the true lumen. If successful crossing is achieved with a conventional guidewire, the CapBuster system will not be utilized. The subject will be a screen failure and will not be considered enrolled in the trial.
If crossing attempt is not successful with a conventional guidewire, the CapBuster system will be utilized. A subject is considered enrolled in the study upon introduction of the CapBuster system into the subject's vasculature. The CapBuster support catheter will be inserted over a conventional guidewire and advanced until the distal tip reaches the CTO cap. The CapBuster 3.0 mm diameter balloon is then inflated to stabilize the system within the arterial vessel. The conventional guidewire is replaced with the CapBuster penetrating wire and, under fluoroscopic guidance, the penetrating wire is manually rotated to penetrate the CTO cap. The balloon pressure may be increased to ensure proper apposition with the vessel wall and maximize stability. Following penetration of the cap, the penetrating wire is replaced with a conventional steerable guidewire. Standard wire escalation techniques will be utilized for continued advancement of the conventional guidewire and complete crossing of the occlusion.
Angiography is performed to confirm guidewire placement. Successful crossing is defined as guidewire placement within the true lumen proximal and distal to the target lesion without utilization of a re-entry device.
After successful crossing is achieved, the target lesion may be treated per Investigator discretion with commercially available devices.
- Conditions
- Chronic Total Occlusion
- Being tested
- CapBuster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapBusterDevice
Evaluate the safety and effectiveness of the CapBuster System in crossing de novo or restenotic chronic total occlusions in infrapopliteal peripheral arteries.
| Study group | Role | What they receive |
|---|---|---|
| CTO proximal cap crossing | Experimental | To demonstrate that CapBuster breaks the proximal cap of CTO's Receives: Device: CapBuster |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
CapBuster system safety from perforations
Freedom from CapBuster System related clinically significant perforations that require intervention
Measured: 12 months
CapBuster system safety from embolizations
Freedom from CapBuster System related clinically significant embolizations that require intervention
Measured: 12 months
CapBuster system safety from dissections
Freedom from CapBuster System related clinically significant flow-limiting (type C, D, E) dissections that require intervention.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start21 Jun 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total OcclusionStudies 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
- Model description
- If crossing the CTO is not successful with a conventional guidewire, the CapBuster system will be used to try to cross the occlusion
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Praxis Medical Devices Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ospedale Regionale di Lugano, St. Antonius Hospital
- Responsible party
- Sponsor
- Investigators
- Jihad Mustapha, Dr, Principal investigator, Advanced Cardiac & Vascular Centers for Amputation Prevention Grand Rapids, MI 49525 USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710342
- Sponsor's protocol ID
- CAP0001
- Acronym
- CapBuster
- Status last verified
- Feb 2023
- First submitted
- 11 Jan 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Medical Device System for the Crossing of Chronic Total Occlusions
- ClinicalTrials.gov ID
- NCT04710342
- Acronym / sponsor ID
- CapBuster / CAP0001
- Conditions
- Chronic Total Occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Praxis Medical Devices LtdIndustry (pharma, biotech, devices)
- Collaborators
- Ospedale Regionale di Lugano, St. Antonius Hospital
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Jan 2021 (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.
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.
Detailed description
The diagnostic and interventional procedure can be conducted via contralateral or antegrade approach and arterial access will be obtained utilizing standard percutaneous techniques and devices. Baseline angiographic images will be obtained prior to the study intervention to confirm the presence of a peripheral arterial occlusion. These images will include the target lesion as well as inflow and outflow with ipsilateral run off to the distal foot. If angiographic imaging confirms that the subject meets enrollment criteria, the enrolled subject will then undergo the study procedure.
If the investigator determines that treatment is required of non-target arterial lesions, the treatment may be performed during the study index procedure according to the investigator's standard practices using commercially available devices.
Prior to utilization of the CapBuster system, the investigator will attempt to cross the target lesion CTO utilizing conventional catheters and guidewires. To minimize vessel trauma, attempted guidewire crossing time will be limited to no more than 5 minutes. The crossing time will begin when the guidewire reaches the lesion CTO cap and will end after occlusion is successfully crossed with confirmed wire placement in the true lumen. If successful crossing is achieved with a conventional guidewire, the CapBuster system will not be utilized. The subject will be a screen failure and will not be considered enrolled in the trial.
If crossing attempt is not successful with a conventional guidewire, the CapBuster system will be utilized. A subject is considered enrolled in the study upon introduction of the CapBuster system into the subject's vasculature. The CapBuster support catheter will be inserted over a conventional guidewire and advanced until the distal tip reaches the CTO cap. The CapBuster 3.0 mm diameter balloon is then inflated to stabilize the system within the arterial vessel. The conventional guidewire is replaced with the CapBuster penetrating wire and, under fluoroscopic guidance, the penetrating wire is manually rotated to penetrate the CTO cap. The balloon pressure may be increased to ensure proper apposition with the vessel wall and maximize stability. Following penetration of the cap, the penetrating wire is replaced with a conventional steerable guidewire. Standard wire escalation techniques will be utilized for continued advancement of the conventional guidewire and complete crossing of the occlusion.
Angiography is performed to confirm guidewire placement. Successful crossing is defined as guidewire placement within the true lumen proximal and distal to the target lesion without utilization of a re-entry device.
After successful crossing is achieved, the target lesion may be treated per Investigator discretion with commercially available devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- If crossing the CTO is not successful with a conventional guidewire, the CapBuster system will be used to try to cross the occlusion
| Arm | Type | Receives |
|---|---|---|
| CTO proximal cap crossing | Experimental | Device: CapBusterTo demonstrate that CapBuster breaks the proximal cap of CTO's |
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 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
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| CapBusterEvaluate the safety and effectiveness of the CapBuster System in crossing de novo or restenotic chronic total occlusions in infrapopliteal peripheral arteries. | Device | CTO proximal cap crossing |
Primary outcome
CTO Crossing
Time frame: 12 months
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.
3 secondary outcomes
CapBuster system safety from perforations
Time frame: 12 months
CapBuster system safety from embolizations
Time frame: 12 months
CapBuster system safety from dissections
Time frame: 12 months
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
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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.
Jihad Mustapha, Dr principal investigator
Advanced Cardiac & Vascular Centers for Amputation Prevention Grand Rapids, MI 49525 USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CapBuster in people with Chronic Total Occlusion, run by Praxis Medical Devices Ltd at 1 site in Netherlands.
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 16 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.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Brendan McLaughlin (353872471662, brendanmclaughlin1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTO Crossing (time frame: 12 months). 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.