Peripheral Arterial DiseaseNCT05110079
Revascularization of Total or Sub-total Occluded Peripheral Arteries With ByCross® Device. Post Market Clinical Followup
An observational study of Peripheral Arterial Disease, run by Taryag Medical Ltd. at 3 sites in Germany.
Trial summary
Post market clinical follow up of Bycross® device. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- ByCross Atherectomy and Thrombectomy
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 3 sitesGermany
- Study dates
- 2 Jun 2021to 31 Mar 2023
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects (male and female) with limb ischemia requiring treatment and target vessel stenosis ≥ 70%
Who may be able to join
- Subject has documented symptomatic chronic peripheral vascular disease at a vessel below the aorta bifurcation
- Candidate for percutaneous intervention
- Severely stenotic occlusion target vessel (stenosis ≥70%)
- Subject has been informed on the nature of the study and has provided informed consent
- Subject is capable of meeting study requirements including presences at follow-up visits
Who cannot join
- Patient anatomy excludes use of BYCROSS® device
- Vessels of the cardiopulmonary, coronary or cerebral circulations
- Undersized vessel diameters (<3mm)
- Perforation of the vessel distally or proximally to the occlusion segment prior atherectomy
- Subintimal position of the guiding catheter or the guidewire
- Use in stents or stent grafts if the guidewire has become threaded at any point in the wire mesh of stent or stent graft or the lining of the stent graft
Show all 14Show fewer
- Target is at vessel segment which includes tortuous course with radius of curvature <= 40mm
- Access pathway includes tortuous course with radius of curvature <= 25mm, in specific extremely sharp aortic bifurcation
- In aneurysmatically altered iliac vessel segments
- If the introducer sheath, the guide catheter, the guidewire or the BYCROSS® sustains any visible damage, especially kinking
- In the fracture areas of broken stents
- Known or suspected allergy to any of the components of the system or to a medicinal product to be administered in connection with the planned procedure
- Persistent vasospasm
- During use of a defibrillator on the patient
Trial locations and contacts
3 sites in 1 country.
Germany3 sites, 3 recruiting
- Recruiting
Karolinen-Hospital, Klinik für Angiologie
Arnsberg, 59755
Simone Muller, +49 2932 952-244826, s.mueller@klinikum-hochsauerland.de
Michael Lichtenberg, M.D.
- Recruiting
Universitätsklinikum Heidelberg
Heidelberg, 69120
Ilka Buss, +49 6221 56-37920, Ilka.Buss@med.uni-heidelberg.de
Christian Erbel, M.D.
- Recruiting
Bonifatius Hospital Lingen
Lingen, 49808
Daniela Viehweider, 0591 910-6121, Daniela.Viehweider@hospital-lingen.de
Joerg Tessarek, M.D.
About this study
Official title: Revascularization of Total or Sub-total Occluded Peripheral Arterial Vessels With ByCross
Post market clinical follow up of Bycross® device.
Read the detailed description
A prospective, multi-center, non-randomized, observational, post market clinical follow-up study of the ByCross® device to evaluate the safety, technical performance and effectiveness of the ByCross® device and effectiveness of the procedure using the device and adjunctive therapy.
The ByCross® is a single use, disposable, minimal invasive aspiration rotational atherectomy device. The ByCross® is aimed to enable effective revascularization and restore blood flow in peripheral occluded vessels. In cases that the artery is completely blocked such that opening is not possible with currently available solutions and the procedure cannot be completed, the device is capable of crossing the blocked lesion without guiding wire and enables the completion of the procedure in a safe and effective manner, thus potentially eliminating the need for open bypass surgery. The ByCross® can be used in several pathologies: calcified atheroma, old and fresh thrombus and in stent restenosis at peripheral arteries including iliac
- Conditions
- Peripheral Arterial Disease
- Being tested
- ByCross Atherectomy and Thrombectomy
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ByCross Atherectomy and ThrombectomyDevice
After assessment of the lesion by angiography the ByCross is advanced over a 0.035" guidewire through a sheath to the occlusion. Activation will rotate the shaft and start aspiration. Under fluoroscopy the ByCross is advanced continuously over the wire. in case passage with guidewire is not possible the ByCross tip is advanced into the occlusion for 10mm, then wire is advanced to check is passage is possible, this is repeated until passage by the wire is achieved. At harder lesion the speed is set to high. Once the occlusion is crossed the ByCross tip is enlarged, device is advanced once more to increase opening. Additional adjunctive treatment may be performed per physician's discretion and according to standard of care. Performance criteria of the complete procedure is to achieved more than 70% opening.
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute procedure success
Passage of the occlusion by the BYCROSS® device and post atherectomy residual stenosis ≤ 50% relative to reference diameter to allow for angioplasty and/or stenting if required, and complete procedural success of residual stenosis ≤ 30%
Measured: Up to 8 hours post-procedure
Freedom from device related serious adverse events
Freedom, at any period between procedure and 90 days post procedure from device related Serious Adverse Events (SADEs) defined by the site as part of the normal reporting practice
Measured: 90 days follow up
Secondary outcomes (4)
Rate of Target vessel revascularization (TVR) at 12 months
Rate of cases of vascular treatment in the same vessel treated during the study
Measured: 12 months
Rate of Target lesion revascularization (TLR) at 12 months
Rate of cases of vascular re-intervention of the same lesion treated during the study
Measured: 12 months
Rutherford classification improvement at 12 months
Improvement in Rutherford classification compared to pre-procedure
Measured: 12 months
Rate of amputations of at 12 months
Rate of amputation of the limb treated during the study
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 posted5 Nov 2021
- Study start2 Jun 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taryag Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joerg Tessarek, M.D., Principal investigator, Bonifatius Hospital Lingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110079
- Sponsor's protocol ID
- QA 366-02
- Status last verified
- Oct 2021
- First submitted
- 26 Oct 2021
- Last updated
- 21 Oct 2022
- 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 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revascularization of Total or Sub-total Occluded Peripheral Arterial Vessels With ByCross
- ClinicalTrials.gov ID
- NCT05110079
- Acronym / sponsor ID
- QA 366-02
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Taryag Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 5 Nov 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.
Post market clinical follow up of Bycross® device.
Detailed description
A prospective, multi-center, non-randomized, observational, post market clinical follow-up study of the ByCross® device to evaluate the safety, technical performance and effectiveness of the ByCross® device and effectiveness of the procedure using the device and adjunctive therapy.
The ByCross® is a single use, disposable, minimal invasive aspiration rotational atherectomy device. The ByCross® is aimed to enable effective revascularization and restore blood flow in peripheral occluded vessels. In cases that the artery is completely blocked such that opening is not possible with currently available solutions and the procedure cannot be completed, the device is capable of crossing the blocked lesion without guiding wire and enables the completion of the procedure in a safe and effective manner, thus potentially eliminating the need for open bypass surgery. The ByCross® can be used in several pathologies: calcified atheroma, old and fresh thrombus and in stent restenosis at peripheral arteries including iliac
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects (male and female) with limb ischemia requiring treatment and target vessel stenosis ≥ 70%
Key inclusion criteria (5 listed)
- Subject has documented symptomatic chronic peripheral vascular disease at a vessel below the aorta bifurcation
- Candidate for percutaneous intervention
- Severely stenotic occlusion target vessel (stenosis ≥70%)
- Subject has been informed on the nature of the study and has provided informed consent
- Subject is capable of meeting study requirements including presences at follow-up visits
Key exclusion criteria (14 listed)
- Patient anatomy excludes use of BYCROSS® device
- Vessels of the cardiopulmonary, coronary or cerebral circulations
- Undersized vessel diameters (<3mm)
- Perforation of the vessel distally or proximally to the occlusion segment prior atherectomy
- Subintimal position of the guiding catheter or the guidewire
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 |
|---|---|---|
| ByCross Atherectomy and ThrombectomyAfter assessment of the lesion by angiography the ByCross is advanced over a 0.035" guidewire through a sheath to the occlusion. Activation will rotate the shaft and start aspiration. Under fluoroscopy the ByCross is advanced continuously over the wire. in case passage with guidewire is not possible the ByCross tip is advanced into the occlusion for 10mm, then wire is advanced to check is passage is possible, this is repeated until passage by the wire is achieved. At harder lesion the speed is set to high. Once the occlusion is crossed the ByCross tip is enlarged, device is advanced once more to increase opening. Additional adjunctive treatment may be performed per physician's discretion and according to standard of care. Performance criteria of the complete procedure is to achieved more than 70% opening. | Device | – |
Primary outcome
Acute procedure success
Time frame: Up to 8 hours post-procedure
Passage of the occlusion by the BYCROSS® device and post atherectomy residual stenosis ≤ 50% relative to reference diameter to allow for angioplasty and/or stenting if required, and complete procedural success of residual stenosis ≤ 30%
Freedom from device related serious adverse events
Time frame: 90 days follow up
Freedom, at any period between procedure and 90 days post procedure from device related Serious Adverse Events (SADEs) defined by the site as part of the normal reporting practice
4 secondary outcomes
Rate of Target vessel revascularization (TVR) at 12 months
Time frame: 12 months
Rate of Target lesion revascularization (TLR) at 12 months
Time frame: 12 months
Rutherford classification improvement at 12 months
Time frame: 12 months
Rate of amputations of at 12 months
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 Oct 2022.
- 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.
Karolinen-Hospital, Klinik für Angiologie
Arnsberg, Germany
Joerg Tessarek, M.D. principal investigator
Bonifatius Hospital Lingen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Taryag Medical Ltd. at 3 sites in Germany.
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 5 inclusion and 14 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 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute procedure success (time frame: Up to 8 hours post-procedure). 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 Oct 2022.