Peripheral Artery Disease (PAD)POINT FORCENCT06687590
Serranator POINT FORCE Registry
An observational study of Peripheral Artery Disease (PAD) and Dysfunctional AV Fistula, run by Cagent Vascular LLC at 19 sites in United States.
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® 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?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease (PAD), Dysfunctional AV Fistula, Dysfunctional AV Graft
- What is being tested?
- Peripheral balloon angioplasty
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 19 sitesUnited States
- Study dates
- 22 Jan 2025to 31 Aug 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population will consist of subjects with claudication or ischemic rest pain, with de novo or restenotic lesions in the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistulae.
Who may be able to join
- Subjects intended to be treated with Serranator® for de-novo or restenotic lesions of the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries or dysfunctional native or synthetic arteriovenous dialysis fistulae.
- Subjects presenting with claudication or critical limb-threatening ischemia (CLTI) by Rutherford Clinical Category 3, 4, 5, or 6 of the target limb.
- Age of subject is > 18.
- Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the approved consent form.
Who cannot join
- Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Serranator® as per Instructions for Use (IFU) or investigator's opinion.
- Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
United States19 sites, 18 recruiting
- Recruiting
Manatee Memorial
Bradenton, Florida, 34208
Camila Vera, (941) 746-5111, camila.vera@novaclinicalresearch.com
S. Jay Mathews, MD
- Recruiting
Atlantic Medical Imaging
Brick, New Jersey, 08724
Melisa Rivera, 856-362-6056 ext. 3571
Nicholas Petruzzi
- Recruiting
Ohio State University Medical Center
Columbus, Ohio, 43210
Subhashish Das, 614-366-6596, subhashish.das@osumc.edu
- Recruiting
Miami Valley Hospital
Dayton, Ohio, 45409
Heather Bell, 937-208-6013, hbell@premierhealth.com
Sagger Mawri
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Renee Bess, (313) 916-2600, rbess1@hfhs.org
Thomas Davis, MD
- Recruiting
Prisma Health
Greenville, South Carolina, 29615
Nikita Kasinger, 864-454-2818, nikita.kasinger@prismahealth.org
Sagar Gandhi
- Recruiting
Hartford HealthCare
Hartford, Connecticut, 06102
Candace Johnson, candace.johnson@hhchealth.org
Edward Gifford, MD
- Recruiting
Radiology and Imaging Specialists
Lakeland, Florida, 33801
Eve Johnson, 352-284-7642, ejohnson@risimaging.com
Michael Campbell
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Ayda Aliyari, (310) 248-7465, ayda.aliyari@cshs.org
Donald Baril
- Recruiting
Virtua Health
Marlton, New Jersey, 08053
Jocelyn Bordelon, 856-355-1225, jbordelo@virtua.org
Luai Tabaza
- Recruiting
Aurora St. Luke's
Milwaukee, Wisconsin, 53215
Reva Matz
Mark Mewissen, MD
- Recruiting
Northwell
New Hyde Park, New York, 11042
Victoria Waimiru, (516) 865 - 8800, mwaimiru@northwell.edu
- Active, not recruiting
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
- Recruiting
Jefferson Einstein
Philadelphia, Pennsylvania, 19141
Vibha Ahuja, 215-456-7231, vibha.ahuja@jefferson.edu
Sahil Banka
- Recruiting
Oregon Health & Sciences University
Portland, Oregon, 97239
Amie Lorisch, 971-349-6659, lorischa@ohsu.edu
Rhusheet Patel
- Recruiting
Brown Health
Providence, Rhode Island, 02912
Bailey Nevins, 401-793-4105
Peter Soukas, MD
- Recruiting
HonorHealth
Scottsdale, Arizona, 85251
Ayda Aliyari, ayda.aliyari@honorhealth.com
Mitri Khoury, MD
- Recruiting
Barnes Jewish
St Louis, Missouri, 63141
Kelly Koogler
Vipul Khetarpaul, MD
- Recruiting
MedStar Washington Hospital / MedStar Montgomery
Washington D.C., District of Columbia, 20010
Kassaye Sesaba, 202-877-8475, kassaye.s.sesaba@medstar.net
Nelson Bernardo, MD
About this study
Official title: POst-Market ClINical Follow-up STudy oF the SerranatOR PTA Serration Balloon CathEter
The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario.
The data and conclusions derived from this study will be used to provide clinical evidence for the clinical evaluation process.
- Being tested
- Peripheral balloon angioplasty
- 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.
Peripheral balloon angioplastyDevice
Serration balloon angioplasty of iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistula
| Study group | Role | What they receive |
|---|---|---|
| Subjects | The study population will consist of subjects with claudication or ischemic rest pain, with de novo or restenotic lesions in the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistulae. Receives: Device: Peripheral balloon angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Endpoint
Device Success defined as the achievement of successful delivery, balloon inflation and deflation, and retrieval of the study device(s) with a post- Serranator® residual stenosis of ≤30% by angiographic core laboratory assessment at the intended target lesion.
Measured: Peri-procedural
Secondary outcomes (1)
Safety Endpoint
Major Adverse Events (MAE) until discharge, defined as all amputations and any re-intervention (surgical or endovascular) in the target limb.
Measured: Peri-procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start22 Jan 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery Disease (PAD)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cagent Vascular LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yale Cardiovascular Research Group, Julius Clinical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687590
- Sponsor's protocol ID
- CSP-0696
- Acronym
- POINT FORCE
- Status last verified
- May 2026
- First submitted
- 12 Nov 2024
- Last updated
- 7 May 2026
- 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 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POst-Market ClINical Follow-up STudy oF the SerranatOR PTA Serration Balloon CathEter
- ClinicalTrials.gov ID
- NCT06687590
- Acronym / sponsor ID
- POINT FORCE / CSP-0696
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cagent Vascular LLCIndustry (pharma, biotech, devices)
- Collaborators
- Yale Cardiovascular Research Group, Julius Clinical
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 13 Nov 2024 (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® in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario.
The data and conclusions derived from this study will be used to provide clinical evidence for the clinical evaluation process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects | – | Device: Peripheral balloon angioplastyThe study population will consist of subjects with claudication or ischemic rest pain, with de novo or restenotic lesions in the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistulae. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of subjects with claudication or ischemic rest pain, with de novo or restenotic lesions in the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistulae.
Key inclusion criteria (4 listed)
- Subjects intended to be treated with Serranator® for de-novo or restenotic lesions of the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries or dysfunctional native or synthetic arteriovenous dialysis fistulae.
- Subjects presenting with claudication or critical limb-threatening ischemia (CLTI) by Rutherford Clinical Category 3, 4, 5, or 6 of the target limb.
- Age of subject is > 18.
- Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the approved consent form.
Key exclusion criteria (2 listed)
- Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Serranator® as per Instructions for Use (IFU) or investigator's opinion.
- Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
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 |
|---|---|---|
| Peripheral balloon angioplastySerration balloon angioplasty of iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistula | Device | Subjects |
Primary outcome
Performance Endpoint
Time frame: Peri-procedural
Device Success defined as the achievement of successful delivery, balloon inflation and deflation, and retrieval of the study device(s) with a post- Serranator® residual stenosis of ≤30% by angiographic core laboratory assessment at the intended target lesion.
1 secondary outcome
Safety Endpoint
Time frame: Peri-procedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
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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.
19 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 Artery Disease (PAD) and Dysfunctional AV Fistula, run by Cagent Vascular LLC at 19 sites in United States.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexis Shewfelt (6502086743, ashewfelt33@cagentvascular.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Endpoint (time frame: Peri-procedural). 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 7 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.