Recruiting

Observational StudySerranator POINT FORCE Registry

Sponsor:

Cagent Vascular LLC

Code:

NCT06687590

Conditions

Peripheral Artery Disease (PAD)

Dysfunctional AV Fistula

Dysfunctional AV Graft

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Peripheral balloon angioplasty

Study Details

Brief 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.

The data and conclusions derived from this study will be used to provide clinical evidence for the clinical evaluation process.

Conditions

Peripheral Artery Disease (PAD)

Dysfunctional AV Fistula

Dysfunctional AV Graft

Study ID

NCT06687590

Start date

Jan 22, 2025

Status verified date

May, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Peripheral balloon angioplasty

Serration balloon angioplasty of iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistula

Primary outcome measure

Performance Endpoint [ Time Frame: Peri-procedural ]

Central Contacts and Locations

Central contacts

Alexis Shewfelt

6502086743 ashewfelt33@cagentvascular.com

Locations

HonorHealth

Recruiting

Scottsdale, Arizona, United States, 85251

Contacts

Ayda Aliyari

ayda.aliyari@honorhealth.com

Principal Investigator:

Mitri Khoury, MD

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Ayda Aliyari

(310) 248-7465 ayda.aliyari@cshs.org

Principal Investigator:

Donald Baril

Hartford HealthCare

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Candace Johnson

candace.johnson@hhchealth.org

Principal Investigator:

Edward Gifford, MD

MedStar Washington Hospital / MedStar Montgomery

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Kassaye Sesaba

202-877-8475 kassaye.s.sesaba@medstar.net

Principal Investigator:

Nelson Bernardo, MD

Manatee Memorial

Recruiting

Bradenton, Florida, United States, 34208

Contacts

Camila Vera

(941) 746-5111 camila.vera@novaclinicalresearch.com

Principal Investigator:

S. Jay Mathews, MD

Radiology and Imaging Specialists

Recruiting

Lakeland, Florida, United States, 33801

Contacts

Eve Johnson

352-284-7642 ejohnson@risimaging.com

Principal Investigator:

Michael Campbell

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Renee Bess

(313) 916-2600 rbess1@hfhs.org

Principal Investigator:

Thomas Davis, MD

Barnes Jewish

Recruiting

St Louis, Missouri, United States, 63141

Principal Investigator:

Vipul Khetarpaul, MD

Atlantic Medical Imaging

Recruiting

Brick, New Jersey, United States, 08724

Contacts

Melisa Rivera

856-362-6056

Principal Investigator:

Nicholas Petruzzi

Virtua Health

Recruiting

Marlton, New Jersey, United States, 08053

Contacts

Jocelyn Bordelon

856-355-1225 jbordelo@virtua.org

Principal Investigator:

Luai Tabaza

Northwell

Recruiting

New Hyde Park, New York, United States, 11042

Contacts

Victoria Waimiru

(516) 865 - 8800 mwaimiru@northwell.edu

Ohio State University Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Subhashish Das

614-366-6596 subhashish.das@osumc.edu

Miami Valley Hospital

Recruiting

Dayton, Ohio, United States, 45409

Contacts

Heather Bell

937-208-6013 hbell@premierhealth.com

Principal Investigator:

Sagger Mawri

Oregon Health & Sciences University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Amie Lorisch

971-349-6659 lorischa@ohsu.edu

Principal Investigator:

Rhusheet Patel

Jefferson Einstein

Recruiting

Philadelphia, Pennsylvania, United States, 19141

Contacts

Vibha Ahuja

215-456-7231 vibha.ahuja@jefferson.edu

Principal Investigator:

Sahil Banka

Brown Health

Recruiting

Providence, Rhode Island, United States, 02912

Contacts

Bailey Nevins

401-793-4105

Principal Investigator:

Peter Soukas, MD

Prisma Health

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

Nikita Kasinger

864-454-2818 nikita.kasinger@prismahealth.org

Principal Investigator:

Sagar Gandhi

Aurora St. Luke's

Recruiting

Milwaukee, Wisconsin, United States, 53215

Principal Investigator:

Mark Mewissen, MD

More Information

Sponsor

Cagent Vascular LLC

Last update posted

May 7, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Cagent Vascular LLC on 2026-05-07.