Peripheral Arterial DiseaseNCT05161039
Serranator Recoil Study
A study testing Serranator and POBA in people with Peripheral Arterial Disease and Critical Limb Ischemia, run by Cagent Vascular LLC at 2 sites in 2 countries.
Trial summary
The study objective is to assess the ability to define and measure post treatment recoil in infrapopliteal arteries. Preliminary evidence as to the differences between serration angioplasty and standard balloon angioplasty as defined by post treatment recoil, lumen gain, and dissection will be collected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Critical Limb Ischemia
- What is being tested?
- Serranator and POBA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Nov 2021to Jul 2022
- 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
- Male or female of >18 years old.
- Women of childbearing potential must have a negative urine pregnancy test within 7 days of index procedure.
- Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and comply, and has signed the consent form.
- Subject has Rutherford Clinical Category 3, 4, 5, or 6.
- Angiographic Inclusion Criteria:
- Target lesion(s) has stenosis >70% by visual assessment;
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- De-novo, or non-stented re-stenotic lesions;
- Reference vessel diameter is between 2.5 mm and 3.5 mm, inclusive;
- Target lesions involve infrapopliteal tibial arteries including pedal;
- A target lesion may consist of one long or multiple serial lesions that are up to and including 12 cm in length;
- If a second lesion is identified in another vessel, the second lesion can also be treated and if treated will be treated with the alternate treatment.
Who cannot join
- Evidence of aneurysm or acute thrombus in the target vessel.
- Subject has an allergy to contrast medium that cannot be pretreated.
- Subject is pregnant or breastfeeding.
- Angiographic Exclusion Criteria:
- Acute Total Occlusions; evidence of acute thrombus formation by angiography.
- In-stent restenotic lesions.
- Inability to cross the lesion with the assigned study device.
- Treatment of target lesion with atherectomy.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94305
Venita Chandra, MD
Germany1 site, 1 recruiting
- Recruiting
Klinik für Angiologie, Klinikum Hochsauerland GmbH
Arnsberg
Stefan Stahlhoff, MD
About this study
Official title: Recoil Feasibility Study for the Treatment of Atherosclerotic Lesions in the Infrapopliteal Arteries Comparing Serration Angioplasty (Serranator® Device) vs. Plain Balloon Angioplasty (POBA)
The study objective is to assess the ability to define and measure post treatment recoil in infrapopliteal arteries. Preliminary evidence as to the differences between serration angioplasty and standard balloon angioplasty as defined by post treatment recoil, lumen gain, and dissection will be collected.
Read the detailed description
Multi-center, feasibility study treating up to 20 atherosclerotic lesions in the infrapopliteal arteries. The study will capture angiographic imaging (pre, during, post, and post 15 mins) for all lesions, and a subset (up to 10) of IVUS imaging data (pre, post, and post 15 mins), to compare serration angioplasty vs standard angioplasty and its effects on vessel recoil and final diameter stenosis.
- Being tested
- Serranator, POBA
- Medical subject headings
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerranatorDevice
Serranator® PTA Serration Balloon Catheter manufactured by Cagent Vascular
POBADevice
Plain balloon angioplasty device
| Study group | Role | What they receive |
|---|---|---|
| Serranator | Other | Not described Receives: Device: Serranator |
| POBA | Other | Not described Receives: Device: POBA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of post treatment recoil
Obtain preliminary data on post treatment recoil in infrapopliteal arteries utilizing angiographic and IVUS data following serration angioplasty and standard angioplasty.
Measured: 15 minutes post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start15 Nov 2021
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cagent Vascular LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161039
- Sponsor's protocol ID
- CSP-0485
- Status last verified
- Jun 2022
- First submitted
- 19 Nov 2021
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recoil Feasibility Study for the Treatment of Atherosclerotic Lesions in the Infrapopliteal Arteries Comparing Serration Angioplasty (Serranator® Device) vs. Plain Balloon Angioplasty (POBA)
- ClinicalTrials.gov ID
- NCT05161039
- Acronym / sponsor ID
- CSP-0485
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cagent Vascular LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 16 Dec 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.
The study objective is to assess the ability to define and measure post treatment recoil in infrapopliteal arteries. Preliminary evidence as to the differences between serration angioplasty and standard balloon angioplasty as defined by post treatment recoil, lumen gain, and dissection will be collected.
Detailed description
Multi-center, feasibility study treating up to 20 atherosclerotic lesions in the infrapopliteal arteries. The study will capture angiographic imaging (pre, during, post, and post 15 mins) for all lesions, and a subset (up to 10) of IVUS imaging data (pre, post, and post 15 mins), to compare serration angioplasty vs standard angioplasty and its effects on vessel recoil and final diameter stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serranator | Other | Device: Serranator |
| POBA | Other | Device: POBA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female of >18 years old.
- Women of childbearing potential must have a negative urine pregnancy test within 7 days of index procedure.
- Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and comply, and has signed the consent form.
- Subject has Rutherford Clinical Category 3, 4, 5, or 6.
- Target lesion(s) has stenosis >70% by visual assessment;
Key exclusion criteria (8 listed)
- Evidence of aneurysm or acute thrombus in the target vessel.
- Subject has an allergy to contrast medium that cannot be pretreated.
- Subject is pregnant or breastfeeding.
- Acute Total Occlusions; evidence of acute thrombus formation by angiography.
- In-stent restenotic lesions.
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 |
|---|---|---|
| SerranatorSerranator® PTA Serration Balloon Catheter manufactured by Cagent Vascular | Device | Serranator |
| POBAPlain balloon angioplasty device | Device | POBA |
Primary outcome
Presence of post treatment recoil
Time frame: 15 minutes post procedure
Obtain preliminary data on post treatment recoil in infrapopliteal arteries utilizing angiographic and IVUS data following serration angioplasty and standard angioplasty.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serranator and POBA in people with Peripheral Arterial Disease and Critical Limb Ischemia, run by Cagent Vascular LLC at 2 sites in 2 countries.
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 11 inclusion and 8 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 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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?
Contact Robert Giasolli (610.688.2006, rgiasolli@cagentvascular.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of post treatment recoil (time frame: 15 minutes post procedure). 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 9 Jun 2022.