Recruiting

Terumo Aortic Grafts, PatchesPANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches

Sponsor:

Vascutek Ltd.

Code:

NCT04545502

Conditions

Aneurysm

Dissection

Aortic Root Aneurysm

Aortic Root Dissection

Carotid Artery Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gelsoft Plus Vascular Graft

Vascular Bypass Graft

Cardiovascular Patch

Gelweave Vascular Graft

Gelweave Valsalva Vascular Graft

Study Details

Brief summary:

The purpose of this registry is to collect safety and performance data on all commercially available Terumo Aortic knitted and woven grafts, and cardiovascular patches in standard clinical practice.

Data will be collected both retrospectively and prospectively.

Conditions

Aneurysm

Dissection

Aortic Root Aneurysm

Aortic Root Dissection

Carotid Artery Injuries

Study ID

NCT04545502

Start date

Feb 17, 2021

Status verified date

Aug, 2026

Completion date

Jan, 2037

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients must meet all of the following inclusion criteria in order to be eligible for inclusion in the study:

All Patients:

Patient meets the minimum age as per local regulations at time of consent
Patient requires treatment with study device(s) according to the IFU(s)
Patient is willing and able to comply with all SOC procedures and study visits
Patient or their legally authorised representative (LAR) has given written informed consent to participate in study, including consent to collect data retrospectively

For prospective emergency patients, retrospective consent is permissible
For retrospective patients who are deceased at time of enrollment, local EC regulations relating to consent process should be followed.

Retrospective Patients only:

Patient has a minimum of 1 year post-operative follow-up data available, or complete data to death.
Patient implant date is no more than 5 years prior to study start date.

Exclusion Criteria:

Any patient who meets any of the following exclusion criteria will be excluded from participation in the study:

Patient is unable or unwilling to comply with the SOC procedures or follow-up regime
Patient is contraindicated per the device IFU
Patient has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre- and post-procedure

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Gelsoft Plus - Straights and Bifurcated

Patients with aneurysmal or occlusive disease, including those with connective tissue disorders who have received/will receive a Gelsoft Plus Straight or Bifurcate, implanted in the abdomen or peripheral arteries in the last 5 years and from study launch onwards.

Gelsoft Plus - Extra-Anatomical

Any patients who have received/will receive a Gelsoft Plus Extra-Anatomical supported or unsupported graft, implanted for: axillary-femoral bypass, femoral-femoral bypass or femoral-popliteal bypass in the last 5 years and from study launch onwards.

Cardiovascular Patches - Gelseal, Gelsoft, Thin Wall

Patients who have been implanted with/require a cardiovascular patch for: thoracic vessel repair with a Gelseal Cardiovascular Patch; abdominal or peripheral vessel repair with a Gelsoft Cardiovascular Patch; or carotid endarterectomy with a Thin Wall Carotid Patch in the last 5 years and from study launch onwards.

Gelweave - Abdominal, Thoracic, Thoracoabdominal

Patients who, due to either aneurysmal or occlusive disease, have had/require vascular repair of one of the following, implanted in the last 5 years and from study launch onwards:

Abdominal aorta, arteries arising from the abdominal aorta or peripheral arteries including femoral, iliac and popliteal arteries.
Thoracic aorta or arteries arising from the thoracic aorta.
Abdominal and thoracic aorta requiring a thoracoabdominal repair

Gelweave - Valsalva

Patients who have had/require aortic root repair using valve sparing or valve replacing procedures, with or without replacement of the aortic arch, implanted in the last 5 years and from study launch onwards.

Interventions

Gelsoft Plus Vascular Graft

Gelatin coated, knitted vascular prosthesis implanted to act as a conduit for channeling blood during repair of damaged or diseased vessels.

Vascular Bypass Graft

Gelatin coated, knitted vascular prosthesis implanted to act as an extra-anatomical bypass for channeling blood during repair of damaged or diseased vessels.

Cardiovascular Patch

Cardiovascular knitted polyester patches are frequently used to treat the carotid or femoral arteries to prevent stroke and repair damage to vessels.

Gelweave Vascular Graft

The Gelweave woven polyester vascular graft allows replacement of large sections of arteries and, following anastomosis to the native blood vessel, provides a stable conduit for blood flow.

Gelweave Valsalva Vascular Graft

This woven polyester graft is designed to match the aortic root anatomy and is implanted to repair or replace a portion of the aorta in case of an aneurysm, dissection or coarctation at the level of the thoracic aorta.

Primary outcome measure

Operative Death [ Time Frame: 1 Year ]
Graft Leakage [ Time Frame: 1 Year ]

Central Contacts and Locations

Central contacts

Clinical Study Manager

+44 141 343 0194 r.smith1@terumoaortic.com

TA UK Clinical Research

+44 141 812 5555 clinicalresearchuk@terumoaortic.com

Locations

University of Colorado Anschutz

Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator:

Brett Reece

University of South Florida - Tampa General

Recruiting

Tampa, Florida, United States, 33620

Contacts

Thanh Tran

tqtran@usf.edu

Principal Investigator:

Murray Shames

Indiana University Health

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Joel Corvera, MD

jcorvera@iuhealth.org

Principal Investigator:

Joel Corvera

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Chad Hughes

gchad.hughes@duke.edu

Principal Investigator:

Chad Hughes

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27858

Contacts

Eddie Hill

Hille19@ecu.edu

Principal Investigator:

Benjamin Degner

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Terence Semenec

terence.semenec@UHhospitals.org

Principal Investigator:

Jae Cho

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator:

Kristine Orion

Lehigh Valley Hospital

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

James Wu

James.Wu@lvhn.org

Principal Investigator:

James Wu

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19105

Contacts

Eric Suchanec

Eric.Suchanec@Pennmedicine.upenn.edu

Principal Investigator:

Nimesh Desai

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Daniel Newton, MD

daniel.newton@vcuhealth.org

Principal Investigator:

Daniel Newton

More Information

Sponsor

Vascutek Ltd.

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

Vascular Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Vascutek Ltd. on 2026-08-20.