Aortic Dissection Type BNCT03033043
Study of the RelayPro Thoracic Stent-Graft in Subjects With an Acute, Complicated Type B Aortic Dissection
A study testing Relay Pro Stent-Graft in people with Aortic Dissection Type B, run by Bolton Medical at 21 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Dissection Type B
- What is being tested?
- Relay Pro Stent-Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 21 sitesUnited States
- Study dates
- 14 Dec 2017to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
- Subject (or Legally Authorized Representative, LAR) agrees to sign an Informed Consent Form prior to treatment.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109-5868
Emory University
Atlanta, Georgia, 30322
University of Colorado Denver
Aurora, Colorado, 80045
University of Maryland Medical Center (UMB)
Baltimore, Maryland, 21201
Buffalo General Medical Center
Buffalo, New York, 14203
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University Hospitals
Cleveland, Ohio, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Hartford Hospital
Hartford, Connecticut, 06102
St. Vincent Heart Center
Indianapolis, Indiana, 46260
University of Iowa Hospital and Clinic
Iowa City, Iowa, 52242
USC Department of Surgery
Los Angeles, California, 90033
Medical College of WI, Vascular Surgery
Milwaukee, Wisconsin, 53226
Yale School of Medicine
New Haven, Connecticut, 06520
Sentara Heart Hospital
Norfolk, Virginia, 22042
University of Pennsylvania Medical Center / Penn Presbyterian
Philadelphia, Pennsylvania, 19104
Providence Heart Institute
Portland, Oregon, 97213
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
University of Washington
Seattle, Washington, 98105
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
About this study
Official title: A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With an Acute, Complicated Type B Aortic Dissection
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.
Read the 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
- Being tested
- Relay Pro Stent-Graft
- Keywords
- aortic, dissection, type B, thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relay Pro Stent-GraftDevice
Also called Relay Pro Stent Graft System
Endovascular treatment of an aortic dissection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Relay Pro Stent-Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality post-procedure
All-cause mortality 30 days post-procedure
Measured: 30 days
Secondary outcomes (3)
Technical Success at the time of the index procedure
Successful delivery and deployment of the device, including withdrawal of the delivery system;
Measured: During deployment of the device
Treatment success through 1 month
- Absence of Major adverse Event (MAE)
- Absence of relevant MAEs:
- Paraplegia;
- Paraparesis;
- New ischemia due to branch vessel compromise;
- Absence of unintentional rupture of the dissection septum;
Measured: 1 month, 6 months, 12 months, and annually through 5 years, defined as individual endpoints and as a composite
Dissection Treatment Success
- Dissection treatment success through 1 month, 6 months, 12 months, and annually through 5 years, defined as individual endpoints and as a composite
Measured: 1, 6, and 12 month follow-up visits, and annually through 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start14 Dec 2017
- Primary completion31 Oct 2021
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Dissection Type BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bolton Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Shults, MD, Principal investigator, Medstar Health Research InstitutePeter Rossi, MD, Principal investigator, Medical College of WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033043
- Sponsor's protocol ID
- IP-0017-16
- Status last verified
- Sep 2025
- First submitted
- 24 Jan 2017
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With an Acute, Complicated Type B Aortic Dissection
- ClinicalTrials.gov ID
- NCT03033043
- Acronym / sponsor ID
- IP-0017-16
- Conditions
- Aortic Dissection Type B
- Keywords
- aortic, dissection, type B, thoracic
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Bolton MedicalIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Relay Pro | Experimental | Device: Relay Pro Stent-GraftThe Relay Pro arm includes subjects who receive the device. The Relay Pro Stent Graft System is administered to treat complicated Type B aortic dissections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- 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 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relay Pro Stent-GraftAlso: Relay Pro Stent Graft SystemEndovascular treatment of an aortic dissection | Device | Experimental: Relay Pro |
Primary outcome
All-cause mortality post-procedure
Time frame: 30 days
All-cause mortality 30 days post-procedure
3 secondary outcomes
Technical Success at the time of the index procedure
Time frame: During deployment of the device
Treatment success through 1 month
Time frame: 1 month, 6 months, 12 months, and annually through 5 years, defined as individual endpoints and as a composite
Dissection Treatment Success
Time frame: 1, 6, and 12 month follow-up visits, and annually through 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Shults, MD principal investigator
Medstar Health Research Institute
Peter Rossi, MD principal investigator
Medical College of WI
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relay Pro Stent-Graft in people with Aortic Dissection Type B, run by Bolton Medical at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality post-procedure (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.