RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers (RelayPro-A)

• ClinicalTrials.gov Identifier: NCT02818972
• Recruitment Status: Recruiting
• First Posted: June 30, 2016
• Last Update Posted: November 16, 2020
• Sponsor: Bolton Medical
• Information provided by (Responsible Party): Bolton Medical

Study Description

Brief Summary:

Investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAU) of the descending thoracic aorta.

Condition or disease	Intervention/treatment	Phase
Aortic Aneurysm, Thoracic; Penetrating Ulcer	Device: RelayPro	Not Applicable

Detailed Description:

The objective of this study is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms and penetrating atherosclerotic ulcers of the descending thoracic aorta.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 110 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers
• Actual Study Start Date: May 10, 2017
• Actual Primary Completion Date: June 24, 2020
• Estimated Study Completion Date: June 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: RelayPro; Endovascular treatment with the investigational device.	Device: RelayPro; Endovascular treatment with investigational device.

Outcome Measures

Primary Outcome Measures :

1. Rate of Major Adverse Events (MAEs) [ Time Frame: 30 days ]

   Primary safety endpoint is a composite of the following MAEs occurring through 30 days:

   • Death
   • Stroke (excluding transient ischemic attack)
   • Paralysis (excludes paraparesis)
2. Technical success [ Time Frame: 24 hours ]

   Primary effectiveness rate as measured by the technical success through 24 hours, defined as:

   • Successful delivery of the device through the vasculature;
   • Successful deployment of the device at the intended location; Absence of Type I or III endoleaks; Patent stent-graft without significant stenosis.
3. Stent graft patency [ Time Frame: 12 months ]
   Primary effectiveness as measured by the rate of stent-graft patency through 12 months.
4. Aneurysm rupture [ Time Frame: 12 months ]
   Primary effectiveness as measured by the absence of aneurysm rupture through 12 months.
5. Absence of Type I and III endoleak through 12 months; [ Time Frame: 12 months ]
   Primary effectiveness as measured by the absence of Type I and III endoleak through 12 months.
6. Absence of stent fractures in the attachment zone through 12 months [ Time Frame: 12 months ]
   Primary effectiveness as measured by the absence of stent fractures in the attachment zone through 12 months.
7. Absence of open or endovascular secondary interventions [ Time Frame: 12 months ]
   Primary effectiveness as measured by the absence of open or endovascular secondary interventions related to the device or treated pathology through 12 months.
8. Absence of aneurysm expansion (> 5 mm diameter increase) [ Time Frame: 12 months ]
   Primary effectiveness as measured by the absence of aneurysm expansion (> 5 mm diameter increase) through 12 months, compared to the first post-procedural computed tomographic (CT) imaging study.
9. Absence of stent-graft migration [ Time Frame: 12 months ]
   Primary effectiveness as measured by the absence of stent-graft migration (> 10 mm) through 12 months, compared to the first post-procedural CT.

Secondary Outcome Measures :

1. Loss of stent-graft patency [ Time Frame: 1 month and 6 months ]
   Loss of stent-graft patency will be assessed with CT scans, or MRIs for subjects unable to tolerate contrast media.
2. Rate of aneurysm rupture [ Time Frame: 1 month and 6 months ]
   The rate of aneurysm rupture through 1 month and 6 months will be assessed by review of CT or MRI imaging, in addition to site reported adverse events.
3. Rate of endoleaks of all types [ Time Frame: 1 month, 6 months and 12 months ]
   Persistence of blood flow outside the lumen of the stent-graft but within the native aorta or adjacent vascular segment being treated by the stent-graft will be assessed by CT scans or MRIs for subjects unable to tolerate contrast media.
4. Rate of stent fractures in the attachment zone [ Time Frame: 1 month and 6 months ]
   Stent fractures in the attachment zone will be assessed at each follow-up visit with CT scans, or MRIs for subjects unable to tolerate contrast media.
5. Incidence of open or endovascular secondary interventions [ Time Frame: 1 month and 6 months ]
   Secondary effectiveness will be measured by the incidence of open or endovascular secondary interventions related to the device or treated pathology (ie, interventions to treat malperfusion, rupture, aneurysm formation, or aortic expansion).
6. Rate of aneurysm expansion [ Time Frame: 1 month and 6 months ]
   The rate of aneurysm expansion (> 5 mm diameter increase) assessed by comparison of follow-up imaging to the first post-procedural CT
7. Rate of stent-graft migration [ Time Frame: 1 month and 6 months ]
   The rate of stent-graft migration (> 10 mm) assessed by comparison of follow-up imaging to the first post-procedural CT.
8. Individual outcomes of composite MAEs [ Time Frame: 6 months and 12 months ]
   Secondary effectiveness as measured by the individual outcomes of the composite safety endpoints (death, stroke, paralysis), as well as myocardial infarction (MI), renal failure, respiratory failure, bowel ischemia, and procedural blood loss >1,000 cc.
9. Rate of vascular access complications [ Time Frame: During the initial implant attempt ]
   Secondary effectiveness as measured by the rate of vascular access complications reported during the Treatment visit (stent-graft implant). Outcome measures include successful delivery and deployment of the device, as well as withdrawal of the delivery system.
10. Duration of implant procedure [ Time Frame: Treatment Visit ]
    Duration of the initial implant procedure captured as the number of minutes from introduction of device to removal of delivery system.
11. Number of blood transfusions [ Time Frame: Treatment Visit through Discharge Visit ]
    Number of transfusions (units) required from the time of implant through hospital discharge.
12. Duration of hospitalization [ Time Frame: Treatment Visit through Discharge Visit ]
    Length of hospital stay defined as number of days subject was hospitalized for the initial implant procedure.
13. Time in Intensive Care Unit (ICU) [ Time Frame: Treatment Visit through Discharge Visit ]
    Duration of time in hours that subject was admitted to the Intensive Care Unit (ICU) following the implant procedure.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Subject must be ≥ 18 years of age
• Subject has specified disease in his/her descending thoracic aorta.
• Subject have anatomical compliance for the device specified for both access vessels and treatment area.
• Subject must be willing to comply with the follow-up evaluation schedule.
• Subject (or Legally Authorized Representative) agrees an Informed Consent Form prior to treatment.

Exclusion Criteria:

• Subject has specified disease of the thoracic aorta which is not included in the trial, for example: aortic dissection, intramural hematoma, traumatic injury or transection, aortic false aneurysm, ruptured aneurysm.
• Subject anatomy with significant stenosis, calcification, thrombus or tortuosity.
• Subjects with specified compromised circulation.
• Subjects with specified prior procedures.
• Subjects with allergy to contrast media or device components.
• Subjects with disease, for example: suspected connective tissue disorder, specified coagulation disorders, specified coronary artery disease, severe congestive heart failure, stroke and/or Myocardial Infarction (MI) as specified, specified pulmonary disease, specified renal failure.
• Subjects that are pregnant or planning to become pregnant during the course of the study.

Contacts and Locations

Contacts

Contact: Valerie DePetrillo; 209-607-7566; v.depetrillo@terumoaortic.com

Locations

United States, Alabama

University of Alabama-Birmingham; Recruiting

Birmingham, Alabama, United States, 35294

Principal Investigator: Benjamin Pearce, MD

United States, Arizona

Arizona Heart Institute; Completed

Phoenix, Arizona, United States, 85006

United States, California

University of California, Irvine; Active, not recruiting

Irvine, California, United States, 92868

Long Beach Memorial Hospital; Recruiting

Long Beach, California, United States, 90806

Principal Investigator: Ali Khoynezhad, MD

United States, Connecticut

Hartford Hospital; Recruiting

Hartford, Connecticut, United States, 06102

Principal Investigator: Akhilesh Jain, MD

United States, Florida

University of Florida; Recruiting

Gainesville, Florida, United States, 32610

Principal Investigator: Martin Back, MD

United States, Georgia

Emory University; Active, not recruiting

Atlanta, Georgia, United States, 30322

United States, Indiana

Indiana University Health; Recruiting

Indianapolis, Indiana, United States, 46202

Principal Investigator: Joel Corvera, MD

St. Vincent Heart Center; Recruiting

Indianapolis, Indiana, United States, 46260

Principal Investigator: Sina Moainie, MD

United States, Iowa

University of Iowa Hospital and Clinic; Recruiting

Iowa City, Iowa, United States, 52242

Principal Investigator: Melhem Sharafuddin, MD

United States, Massachusetts

Tufts Medical Center; Recruiting

Boston, Massachusetts, United States, 02111

Principal Investigator: Payam Salehi, MD

Beth Israel Deaconess Medical Center / Harvard Medical School; Active, not recruiting

Boston, Massachusetts, United States, 02215

Baystate Medical Center; Active, not recruiting

Springfield, Massachusetts, United States, 01199

United States, Michigan

University of Michigan; Active, not recruiting

Ann Arbor, Michigan, United States, 48109

United States, New Jersey

Newark Beth Israel Medical Center; Active, not recruiting

Newark, New Jersey, United States, 07112

United States, New York

New York University; Recruiting

New York, New York, United States, 10016

Principal Investigator: Neal Cayne, MD

United States, North Carolina

East Carolina University Brody School of Medicine; Active, not recruiting

Greenville, North Carolina, United States, 27834

United States, Ohio

University Hospitals; Active, not recruiting

Cleveland, Ohio, United States, 44106

Cleveland Clinic Foundation; Recruiting

Cleveland, Ohio, United States, 44195

Principal Investigator: Christopher Smolock, MD

United States, Pennsylvania

University of Pennsylvania Medical Center / Penn Presbyterian; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator: Wilson Szeto, MD

Lankenau Medical Center; Recruiting

Wynnewood, Pennsylvania, United States, 19096

Principal Investigator: Robert Meisner, MD

United States, Tennessee

Centennial Heart & Vascular Institute Sarah Cannon Research Institute; Completed

Nashville, Tennessee, United States, 37203

Vanderbilt University Medical Center; Recruiting

Nashville, Tennessee, United States, 37232

Principal Investigator: Thomas Naslund, MD

United States, Texas

University of Texas Southwestern; Active, not recruiting

Dallas, Texas, United States, 75390

Baylor Scott & White Medical Center - Plano The Heart Hospital; Recruiting

Plano, Texas, United States, 75093

Principal Investigator: William Brinkman, MD

Baylor Scot & White Medical Center - Temple; Recruiting

Temple, Texas, United States, 76508

Principal Investigator: Robert Smith, MD

Japan

Nagoya University Hospital; Active, not recruiting

Nagoya, Aichi, Japan

Teine Keihinkai Hospital; Active, not recruiting

Sapporo, Hokkaido, Japan

Nara Medical University Hospital; Active, not recruiting

Kashihara, Nara, Japan

Niigata University Medical & Dental Hospital; Active, not recruiting

Niigata City, Niigata, Japan

Oita University Hospital; Active, not recruiting

Yufu City, Oita, Japan

Morinomiya Hospital; Active, not recruiting

Joto-ku, Osaka, Japan

National Cerebral & Cardiovascular Center; Active, not recruiting

Suita, Osaka, Japan

Jichi Medical University Saitama Medical Center; Active, not recruiting

Ōmiya, Saitama, Japan

Jikei University Hospital; Active, not recruiting

Minato-Ku, Tokyo, Japan

Keio University Hospital; Active, not recruiting

Shinjuku-Ku, Tokyo, Japan

Hiroshima University Hospital; Active, not recruiting

Hiroshima, Japan

Sponsors and Collaborators

Bolton Medical

Investigators

• Principal Investigator: Wilson Szeto, MD; Penn Presbyterian
• Principal Investigator: Venkatesh Ramaiah, MD; Arizona Heart Institute

More Information

• Responsible Party: Bolton Medical
• ClinicalTrials.gov Identifier: NCT02818972
• Other Study ID Numbers: IP-0015-16
• First Posted: June 30, 2016
• Last Update Posted: November 16, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Ulcer; Pathologic Processes; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases