Study of the RelayPro Thoracic Stent-Graft in Subjects With an Acute, Complicated Type B Aortic Dissection

NCT ID: NCT03033043

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-14
• Study Completion Date: 2026-11-30

Brief Summary

This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B aortic dissection. The primary endpoint will measure all-cause mortality at 30 days post-procedure.

Detailed Description

This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B aortic dissection. The primary endpoint will measure all-cause mortality at 30 days post-procedure.

Subjects will be enrolled on a first come, first serve basis; however, no single investigational site may enroll more than 20% of the proposed sample size of up to 80 subjects. A subject is considered enrolled when arterial access is gained and an attempt is made to introduce the RelayPro Thoracic Stent-Graft. Enrollment is expected to begin in mid-2016 and complete by the end of 2020.

All subjects enrolled, as defined above, will be included in the patient population for the primary safety analyses. All subjects implanted with the RelayPro Thoracic Stent-Graft will be included in the patient population for the primary effectiveness analyses.

Conditions

Aortic Dissection Type B

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Relay Pro

The Relay Pro arm includes subjects who receive the device. The Relay Pro Stent Graft System is administered to treat complicated Type B aortic dissections.

Group Type: EXPERIMENTAL

Relay Pro Stent-Graft

Intervention Type: DEVICE

Endovascular treatment of an aortic dissection

Interventions

Relay Pro Stent-Graft

Endovascular treatment of an aortic dissection

Intervention Type: DEVICE

Other Intervention Names

Relay Pro Stent Graft System

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bolton Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Shults, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Peter Rossi, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of WI

Locations

USC Department of Surgery

Los Angeles, California, United States

University of Colorado Denver

Aurora, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Yale School of Medicine

New Haven, Connecticut, United States

Medstar Washington Hospital Center

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

Emory University

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

St. Vincent Heart Center

Indianapolis, Indiana, United States

University of Iowa Hospital and Clinic

Iowa City, Iowa, United States

University of Maryland Medical Center (UMB)

Baltimore, Maryland, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Buffalo General Medical Center

Buffalo, New York, United States

University Hospitals

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Providence Heart Institute

Portland, Oregon, United States

University of Pennsylvania Medical Center / Penn Presbyterian

Philadelphia, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Sentara Heart Hospital

Norfolk, Virginia, United States

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States

University of Washington

Seattle, Washington, United States

Medical College of WI, Vascular Surgery

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

IP-0017-16

Identifier Type: -

Identifier Source: org_study_id