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

NCT03033043 | Active Not Recruiting DMC FDA Device

• 1 other identifier: IP-0017-16
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 21

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.

Conditions

Aortic Dissection Type B

Keywords

aortic; dissection; type B; thoracic

Outcome Measures

Primary Outcomes (1)

• All-cause mortality post-procedure

  All-cause mortality 30 days post-procedure

  30 days

Secondary Outcomes (3)

• Technical Success at the time of the index procedure

  During deployment of the device

• Treatment success through 1 month

  1 month, 6 months, 12 months, and annually through 5 years, defined as individual endpoints and as a composite

• Dissection Treatment Success

  1, 6, and 12 month follow-up visits, and annually through 5 years.

Study Arms (1)

Experimental: Relay Pro

EXPERIMENTAL

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.

Device: Relay Pro Stent-Graft

Interventions

Relay Pro Stent-Graft DEVICE

Endovascular treatment of an aortic dissection

Also known as: Relay Pro Stent Graft System

Experimental: Relay Pro

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.)
• The length of the attachment zones will depend on the intended stent-graft diameter and type of graft selected.
• 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).
• The distal attachment zone should be 20 mm for all RelayPro grafts.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bolton Medical: lead

Study Sites (21)

USC Department of Surgery

Los Angeles, California, 90033, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

Medstar Washington Hospital Center

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

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

St. Vincent Heart Center

Indianapolis, Indiana, 46260, United States

Location

University of Iowa Hospital and Clinic

Iowa City, Iowa, 52242, United States

Location

University of Maryland Medical Center (UMB)

Baltimore, Maryland, 21201, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109-5868, United States

Location

Buffalo General Medical Center

Buffalo, New York, 14203, United States

Location

University Hospitals

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Providence Heart Institute

Portland, Oregon, 97213, United States

Location

University of Pennsylvania Medical Center / Penn Presbyterian

Philadelphia, Pennsylvania, 19104, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Sentara Heart Hospital

Norfolk, Virginia, 22042, United States

Location

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

Location

University of Washington

Seattle, Washington, 98105, United States

Location

Medical College of WI, Vascular Surgery

Milwaukee, Wisconsin, 53226, United States

Location

Study Officials

• Christian Shults, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

• Peter Rossi, MD

  Medical College of WI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: January 26, 2017
• Study Start: December 14, 2017
• Primary Completion: October 31, 2021
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)