New stent aims to save lives from aortic tear

NCT ID NCT03033043

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 device called the RelayPro Stent-Graft in 56 people with a sudden, complicated tear in the main artery (type B aortic dissection). The goal is to see if the stent can reduce deaths within 30 days. Participants receive the stent to repair the tear and prevent serious problems like organ damage.

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

56 people

The number who actually took part.

Started

Dec 2017

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Subject must have an acute (symptom onset to diagnosis within 2 weeks)or subacute, complicated type B aortic dissection (entire dissection is distal to the left subclavian artery (LSA)), confirmed by Computed Tomography Angiography (CTA) or Magnetic Resonance Angiogram (MRA), with time from symptom onset to diagnosis ≤ 6 weeks, with at least one of the following: * Malperfusion of the viscera, kidneys, spinal cord, or lower extremities, measured by clinical or radiographic evidence; * Rupture; * Intractable pain. * Proximal and distal aortic neck with diameter between 19 mm and 42 mm. * Subject's anatomy must meet all of the following anatomical criteria: 1. Proximal attachment zone distal to the left common carotid and a distal attachment zone proximal to the origin of the celiac artery. (Dissection is permitted in the distal attachment zone but is not permitted in the proximal attachment zone.) 2. The length of the attachment zones will depend on the intended stent-graft diameter and type of graft selected. 3. The proximal attachment zone should be 15 mm for 22 - 28 mm RelayPro grafts with bare stent (20 mm for RelayPro grafts with non-bare stent), 20 mm for 30 - 46 mm RelayPro grafts with bare stent (25 mm for RelayPro grafts with non-bare stent), and proximal to non-dissected segment (healthy zone). 4. The distal attachment zone should be 20 mm for all RelayPro grafts. 5. Coverage of the left subclavian artery is permitted with mandatory revascularization if patent left internal mammary artery (LIMA) bypass or left upper extremity (LUE) arteriovenous graft or anomalous vertebral artery off the aorta. Revascularization must be performed prior to device placement, and may occur during implant procedure, provided it is before coverage of the LSA by the endograft. * Proximal attachment zone containing a straight segment (non-tapered, non-reverse-tapered, defined by \<10% diameter change) with lengths equal to or greater than the required attachment length for the intended device. * Vascular dimensions (e.g., aortic diameters, length from left subclavian to celiac artery) must be in the range that can be safely treated with the RelayPro Thoracic Stent-Grafts. * Adequate iliac or femoral artery access for introduction of the RelayPro Delivery System. Alternative methods to gain proper access may be utilized (e.g., iliac conduit). * Subject willing to comply with the follow-up evaluation schedule. * Subject (or Legally Authorized Representative, LAR) agrees to sign an Informed Consent Form prior to treatment. Exclusion Criteria: * Diagnosis of traumatic injury or transection of the descending thoracic aorta. * Significant stenosis, calcification, thrombus, or tortuosity of intended fixation sites that would compromise fixation or seal of the device. * Planned coverage of left carotid or celiac arteries; or anatomic variants that would compromise circulation to the carotid, vertebral, or innominate arteries after device placement, which is not amenable to subclavian revascularization. * Prior endovascular or surgical repair in the descending thoracic aorta. The device may not be placed within any prior endovascular or surgical graft. * Concomitant aneurysm/disease of the ascending aorta, aortic arch, or abdominal aorta, requiring repair. Dissection extension into the abdominal aorta is acceptable. * Prior abdominal aortic aneurysm repair (endovascular or surgical) that was performed less than 6 months prior to the planned stent implant procedure. * Major surgical or medical procedure within 30 days prior to the planned procedure, or is scheduled for a major surgical or medical procedure within 30 days post implantation. This excludes any planned procedures for the prospective stent-graft placement. * Untreatable allergy or sensitivity to contrast media or device components, including metal stents. * Known or suspected connective tissue disorder. * Blood coagulation disorder or bleeding diathesis for which the treatment cannot be suspended for one week pre- and/or post-repair. * Coronary artery disease with unstable angina. * Severe congestive heart failure (New York Heart Association functional class IV). * Stroke and/or Myocardial Infarction (MI) within 3 months of the planned treatment date. * Pulmonary disease requiring the routine (daily or nightly) need for oxygen therapy outside the hospital setting. * Acute renal failure or chronic renal insufficiency, and not receiving dialysis. * Hemodynamically unstable. * Active systemic infection and/or mycotic aneurysms. * Bowel necrosis. * Morbid obesity or other condition that may compromise or prevent the necessary imaging requirements. * ASA risk classification = V (Moribund patient not expected to live 24 hours with or without operation). * Less than two-year life expectancy. * Current or planned participation in an investigational drug or device study that has not completed primary endpoint evaluation. * Currently pregnant or planning to become pregnant during the course of the study. * Medical, social, or psychological issues that Investigator believes may interfere with treatment or follow-up.

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Buffalo General Medical Center

    Buffalo, New York, 14203, United States

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24014, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Hartford Hospital

    Hartford, Connecticut, 06102, United States

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096, United States

  • Medical College of WI, Vascular Surgery

    Milwaukee, Wisconsin, 53226, United States

  • Medstar Washington Hospital Center

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

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Providence Heart Institute

    Portland, Oregon, 97213, United States

  • Sentara Heart Hospital

    Norfolk, Virginia, 22042, United States

  • St. Vincent Heart Center

    Indianapolis, Indiana, 46260, United States

  • USC Department of Surgery

    Los Angeles, California, 90033, United States

  • University Hospitals

    Cleveland, Ohio, 44106, United States

  • University of Colorado Denver

    Aurora, Colorado, 80045, United States

  • University of Iowa Hospital and Clinic

    Iowa City, Iowa, 52242, United States

  • University of Maryland Medical Center (UMB)

    Baltimore, Maryland, 21201, United States

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109-5868, United States

  • University of Pennsylvania Medical Center / Penn Presbyterian

    Philadelphia, Pennsylvania, 19104, United States

  • University of Washington

    Seattle, Washington, 98105, United States

  • Yale School of Medicine

    New Haven, Connecticut, 06520, United States

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