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New stent procedure could tame deadly aortic bulges without major surgery

NCT ID NCT00483249

Disease control Sponsor: Warren J. Gasper, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a minimally invasive procedure to treat large aneurysms in the aorta (the main artery) in the chest and belly area. Instead of open surgery, doctors place a fabric-covered metal tube (stent-graft) inside the aneurysm to seal it off. The goal is to see if this approach is safe and works well for people with aneurysms at least 5.5-6 cm wide or growing quickly. About 250 participants will be followed for long-term success.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Start date

May 2005

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Aortic aneurysms: * greater than or equal to 6 cm in diameter in men, * greater than or equal to 5.5 cm in diameter in women, * and/or larger than 5 cm in diameter and enlarging at a rate of more than 5 mm/year, * and/or iliac aneurysms larger than 4 cm in diameter. 2. Anticipated mortality comparable to published rates with conventional surgical treatment. 3. Life expectancy more than 2 years. 4. Ability to give informed consent. 5. Willingness to comply with follow-up schedule. 6. Suitable arterial anatomy for endovascular repair. Exclusion Criteria 1. Free rupture of the aneurysm. 2. Pregnancy. 3. Known allergy to Nitinol, stainless steel, or polyester. 4. Unwillingness or inability to comply with the follow up schedule. 5. Serious systemic or groin infection. 6. Uncorrectable coagulopathy.

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Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm Aneurysm aortic aneurysm Aortic Aneurysm, Thoracoabdominal thoracic aortic aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Paravisceral abdominal aortic aneurysm Thoracoabdominal aortic aneurysm

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Division of Vascular Surgery, SFVAMC

    RECRUITING

    San Francisco, California, 94121, United States

  • Division of Vascular Surgery, UCSF

    RECRUITING

    San Francisco, California, 94143, United States

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