Peripheral Arterial DiseaseNCT03538392
Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
An observational study of Peripheral Arterial Disease and Arterio-venous Fistula, run by Cagent Vascular LLC.
Trial summary
The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® Alto in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Arterial Disease, Arterio-venous Fistula, Arteriovenous Graft
- What is being tested?
- Serranator® Alto
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Dec 2019
- How long will I take part?
- 1 Day
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will consist of subjects with claudication or ischemic rest pain, requiring dilatation of lesions, in the iliac or femoropopliteal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistulae.
- Subject requires angioplasty
- Subject has a lesion in the iliac, femoral, iliofemoral, popliteal artery, or obstructive lesion of native or synthetic arteriovenous dialysis fistulae as per the product indications for use
About this study
Official title: Post Market Clinical Follow-up Study - PMCF Study, Serranator® Alto
The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® Alto in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario.
Read the detailed description
Single Arm, multi-center, device registry study capturing de-identified data on a minimum of 100 subjects with peripheral artery disease (PAD) and/or dysfunctional native or synthetic arteriovenous dialysis fistulae. The study will capture acute angiographic data.
- Being tested
- Serranator® Alto
- Medical subject headings
- Peripheral Arterial Disease, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serranator® AltoDevice
Serranator® Alto PTA Serration Balloon Catheter
| Study group | Role | What they receive |
|---|---|---|
| PAD | Not described Receives: Device: Serranator® Alto | |
| AV Fistula | Not described Receives: Device: Serranator® Alto | |
| AV Graft | Not described Receives: Device: Serranator® Alto |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance
Device Success defined as the achievement of successful delivery, balloon inflation and deflation, and retrieval of the study device(s) with a diameter stenosis of <50% by visual assessment at the intended target site after using the Serranator® device.
Measured: The registry will collect acute procedural data through hospital discharge, no additional follow up is required. Performance data will be summarized after enrollment is complete, estimated to be 1 year.
Secondary outcomes (1)
Collection of device related Major Adverse Events (MAE) until discharge
Safety defined as incidence of device related MAE, defined as amputations or re-interventions (surgical or endovascular)
Measured: Within 12-24 hours post-procedure or prior to hospital discharge, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study startSep 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Product not available, study withdrawn
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
- 0 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cagent Vascular LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538392
- Sponsor's protocol ID
- Serranator® Alto PMCF Study
- Status last verified
- Jul 2019
- First submitted
- 24 Apr 2018
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-up Study - PMCF Study, Serranator® Alto
- ClinicalTrials.gov ID
- NCT03538392
- Acronym / sponsor ID
- Serranator® Alto PMCF Study
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Product not available, study withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cagent Vascular LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 29 May 2018 (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 objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® Alto in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario.
Detailed description
Single Arm, multi-center, device registry study capturing de-identified data on a minimum of 100 subjects with peripheral artery disease (PAD) and/or dysfunctional native or synthetic arteriovenous dialysis fistulae. The study will capture acute angiographic data.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PAD | – | Device: Serranator® Alto |
| AV Fistula | – | Device: Serranator® Alto |
| AV Graft | – | Device: Serranator® Alto |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of subjects with claudication or ischemic rest pain, requiring dilatation of lesions, in the iliac or femoropopliteal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistulae.
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 |
|---|---|---|
| Serranator® AltoSerranator® Alto PTA Serration Balloon Catheter | Device | AV Fistula, AV Graft, PAD |
Primary outcome
Performance
Time frame: The registry will collect acute procedural data through hospital discharge, no additional follow up is required. Performance data will be summarized after enrollment is complete, estimated to be 1 year.
Device Success defined as the achievement of successful delivery, balloon inflation and deflation, and retrieval of the study device(s) with a diameter stenosis of <50% by visual assessment at the intended target site after using the Serranator® device.
1 secondary outcome
Collection of device related Major Adverse Events (MAE) until discharge
Time frame: Within 12-24 hours post-procedure or prior to hospital discharge, whichever occurs first
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Arterio-venous Fistula, run by Cagent Vascular LLC.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Apr 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Performance (time frame: The registry will collect acute procedural data through hospital discharge, no additional follow up is required. Performance data will be summarized after enrollment is complete, estimated to be 1 year.). 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 10 Apr 2020.