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

• Sponsor: Bolton Medical (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02818972
• Collaborator: (none)
• Enrollment: 110
• Locations: 37
• Arm: 1
• Anticipated Duration (Months): 84.7
• Patients Per Site: 3
• Patients Per Site Per Month: 0

Study Details

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	N/A

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
• Anticipated 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
• Anticipated Primary Completion Date: Jun 24, 2022
• Anticipated Study Completion Date: Jun 1, 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) [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 [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 [12 months]

   Primary effectiveness as measured by the rate of stent-graft patency through 12 months.

4. Aneurysm rupture [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; [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 [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 [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) [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [Treatment Visit through Discharge Visit]

    Number of transfusions (units) required from the time of implant through hospital discharge.

12. Duration of hospitalization [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) [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama-Birmingham	Birmingham	Alabama	United States	35294
2	Arizona Heart Institute	Phoenix	Arizona	United States	85006
3	University of California, Irvine	Irvine	California	United States	92868
4	Long Beach Memorial Hospital	Long Beach	California	United States	90806
5	Hartford Hospital	Hartford	Connecticut	United States	06102
6	University of Florida	Gainesville	Florida	United States	32610
7	Emory University	Atlanta	Georgia	United States	30322
8	Indiana University Health	Indianapolis	Indiana	United States	46202
9	St. Vincent Heart Center	Indianapolis	Indiana	United States	46260
10	University of Iowa Hospital and Clinic	Iowa City	Iowa	United States	52242
11	Tufts Medical Center	Boston	Massachusetts	United States	02111
12	Beth Israel Deaconess Medical Center / Harvard Medical School	Boston	Massachusetts	United States	02215
13	Baystate Medical Center	Springfield	Massachusetts	United States	01199
14	University of Michigan	Ann Arbor	Michigan	United States	48109
15	Newark Beth Israel Medical Center	Newark	New Jersey	United States	07112
16	New York University	New York	New York	United States	10016
17	East Carolina University Brody School of Medicine	Greenville	North Carolina	United States	27834
18	University Hospitals	Cleveland	Ohio	United States	44106
19	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
20	University of Pennsylvania Medical Center / Penn Presbyterian	Philadelphia	Pennsylvania	United States	19104
21	Lankenau Medical Center	Wynnewood	Pennsylvania	United States	19096
22	Centennial Heart & Vascular Institute Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
23	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
24	University of Texas Southwestern	Dallas	Texas	United States	75390
25	Baylor Scott & White Medical Center - Plano The Heart Hospital	Plano	Texas	United States	75093
26	Baylor Scot & White Medical Center - Temple	Temple	Texas	United States	76508
27	Nagoya University Hospital	Nagoya	Aichi	Japan
28	Teine Keihinkai Hospital	Sapporo	Hokkaido	Japan
29	Nara Medical University Hospital	Kashihara	Nara	Japan
30	Niigata University Medical & Dental Hospital	Niigata City	Niigata	Japan
31	Oita University Hospital	Yufu City	Oita	Japan
32	Morinomiya Hospital	Joto-ku	Osaka	Japan
33	National Cerebral & Cardiovascular Center	Suita	Osaka	Japan
34	Jichi Medical University Saitama Medical Center	Ōmiya	Saitama	Japan
35	Jikei University Hospital	Minato-Ku	Tokyo	Japan
36	Keio University Hospital	Shinjuku-Ku	Tokyo	Japan
37	Hiroshima University Hospital	Hiroshima		Japan

Sponsors and Collaborators

• Bolton Medical

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bolton Medical
• ClinicalTrials.gov Identifier: NCT02818972
• Other Study ID Numbers: IP-0015-16
• First Posted: Jun 30, 2016
• Last Update Posted: May 16, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

No Results Posted as of May 16, 2022