An observational study in Aneurysm, Dissection and Aortic Root Aneurysm, sponsored by Vascutek Ltd.. Recruiting at 30 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Vascutek Ltd. (part of Terumo Corporation) · Observational
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.
381 studies on the registry are indexed under Aneurysm; 78 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 157 across 132 observational studies indexed under Aneurysm.
Browse Aneurysm studies →Vascutek Ltd. is the lead sponsor of 17 studies on the registry; 5 are open to participants now.
First submitted after Vascutek Ltd. became part of Terumo Corporation.
Counted across the registry records on this site, refreshed daily.
Patients who require treatment, or have already received treatment within the last 5 years, with the following commercially available Terumo Aortic knitted and woven grafts and cardiovascular patches:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All Patients:
Patient or their legally authorised representative (LAR) has given written to participate in study, including consent to collect data retrospectively
Retrospective Patients only:
Exclusion Criteria:
Any patient who meets any of the following exclusion criteria will be excluded from participation in the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Gelsoft Plus Vascular Graft
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.
Device: Vascular Bypass Graft
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.
Device: Cardiovascular Patch
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
Device: Gelweave Vascular Graft
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.
Device: Gelweave Valsalva Vascular Graft
Gelatin coated, knitted vascular prosthesis implanted to act as a conduit for channeling blood during repair of damaged or diseased vessels.
Also known as: Gelsoft Plus
Gelatin coated, knitted vascular prosthesis implanted to act as an extra-anatomical bypass for channeling blood during repair of damaged or diseased vessels.
Also known as: Gelsoft Plus Extra Anatomical
Cardiovascular knitted polyester patches are frequently used to treat the carotid or femoral arteries to prevent stroke and repair damage to vessels.
Also known as: Gelseal Patch, Gelsoft Patch, Thinwall Patch, Cardiovascular Fabrics
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.
Also known as: Gelweave
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.
Also known as: Gelweave Valsalva
Operative Death
30 Day or In-Hospital Mortality
Time frame: 1 Year
Graft Leakage
Device Failure: The presence of leakage or excessive bleeding through graft/patch
Time frame: 1 Year
Device Endpoints
Device failures, requirement for reintervention or device related adverse events
Time frame: 1 Year
Procedural Endpoints
Rifampicin or heparin soaking, procedure related adverse events
Time frame: 1 Year
Safety Endpoints
Occurrence of the following: Mortality, Ischemia, Occlusion, Thrombosis, Haemmorrhage, Rupture, Pseudoaneurysm, Stroke
Time frame: 1 Year
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Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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