Back to resultsRelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers (RelayPro-A)
Primary Purpose
Aortic Aneurysm, Thoracic, Penetrating Ulcer
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
RelayPro
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Aneurysm, Thoracic
Eligibility 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.
Sites / Locations
- University of Alabama-Birmingham
- Arizona Heart Institute
- University of California, Irvine
- Long Beach Memorial Hospital
- Hartford Hospital
- University of Florida
- Emory University
- Indiana University Health
- St. Vincent Heart Center
- University of Iowa Hospital and Clinic
- Tufts Medical Center
- Beth Israel Deaconess Medical Center / Harvard Medical School
- Baystate Medical Center
- University of Michigan
- Newark Beth Israel Medical Center
- New York University
- East Carolina University Brody School of Medicine
- University Hospitals
- Cleveland Clinic Foundation
- University of Pennsylvania Medical Center / Penn Presbyterian
- Lankenau Medical Center
- Centennial Heart & Vascular Institute Sarah Cannon Research Institute
- Vanderbilt University Medical Center
- University of Texas Southwestern
- Baylor Scott & White Medical Center - Plano The Heart Hospital
- Baylor Scot & White Medical Center - Temple
- Nagoya University Hospital
- Teine Keihinkai Hospital
- Nara Medical University Hospital
- Niigata University Medical & Dental Hospital
- Oita University Hospital
- Morinomiya Hospital
- National Cerebral & Cardiovascular Center
- Jichi Medical University Saitama Medical Center
- Jikei University Hospital
- Keio University Hospital
- Hiroshima University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RelayPro
Arm Description
Endovascular treatment with the investigational device.
Outcomes
Primary Outcome Measures
Rate of Major Adverse Events (MAEs)
Primary safety endpoint is a composite of the following MAEs occurring through 30 days:
Death
Stroke (excluding transient ischemic attack)
Paralysis (excludes paraparesis)
Technical success
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.
Stent graft patency
Primary effectiveness as measured by the rate of stent-graft patency through 12 months.
Aneurysm rupture
Primary effectiveness as measured by the absence of aneurysm rupture through 12 months.
Absence of Type I and III endoleak through 12 months;
Primary effectiveness as measured by the absence of Type I and III endoleak through 12 months.
Absence of stent fractures in the attachment zone through 12 months
Primary effectiveness as measured by the absence of stent fractures in the attachment zone through 12 months.
Absence of open or endovascular secondary interventions
Primary effectiveness as measured by the absence of open or endovascular secondary interventions related to the device or treated pathology through 12 months.
Absence of aneurysm expansion (> 5 mm diameter increase)
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.
Absence of stent-graft migration
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
Loss of stent-graft patency
Loss of stent-graft patency will be assessed with CT scans, or MRIs for subjects unable to tolerate contrast media.
Rate of aneurysm rupture
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.
Rate of endoleaks of all types
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.
Rate of stent fractures in the attachment zone
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.
Incidence of open or endovascular secondary interventions
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).
Rate of aneurysm expansion
The rate of aneurysm expansion (> 5 mm diameter increase) assessed by comparison of follow-up imaging to the first post-procedural CT
Rate of stent-graft migration
The rate of stent-graft migration (> 10 mm) assessed by comparison of follow-up imaging to the first post-procedural CT.
Individual outcomes of composite MAEs
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.
Rate of vascular access complications
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.
Duration of implant procedure
Duration of the initial implant procedure captured as the number of minutes from introduction of device to removal of delivery system.
Number of blood transfusions
Number of transfusions (units) required from the time of implant through hospital discharge.
Duration of hospitalization
Length of hospital stay defined as number of days subject was hospitalized for the initial implant procedure.
Time in Intensive Care Unit (ICU)
Duration of time in hours that subject was admitted to the Intensive Care Unit (ICU) following the implant procedure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02818972
Brief Title
RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers
Acronym
RelayPro-A
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
June 24, 2022 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bolton Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Thoracic, Penetrating Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RelayPro
Arm Type
Experimental
Arm Description
Endovascular treatment with the investigational device.
Intervention Type
Device
Intervention Name(s)
RelayPro
Intervention Description
Endovascular treatment with investigational device.
Primary Outcome Measure Information:
Title
Rate of Major Adverse Events (MAEs)
Description
Primary safety endpoint is a composite of the following MAEs occurring through 30 days:
Death
Stroke (excluding transient ischemic attack)
Paralysis (excludes paraparesis)
Time Frame
30 days
Title
Technical success
Description
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.
Time Frame
24 hours
Title
Stent graft patency
Description
Primary effectiveness as measured by the rate of stent-graft patency through 12 months.
Time Frame
12 months
Title
Aneurysm rupture
Description
Primary effectiveness as measured by the absence of aneurysm rupture through 12 months.
Time Frame
12 months
Title
Absence of Type I and III endoleak through 12 months;
Description
Primary effectiveness as measured by the absence of Type I and III endoleak through 12 months.
Time Frame
12 months
Title
Absence of stent fractures in the attachment zone through 12 months
Description
Primary effectiveness as measured by the absence of stent fractures in the attachment zone through 12 months.
Time Frame
12 months
Title
Absence of open or endovascular secondary interventions
Description
Primary effectiveness as measured by the absence of open or endovascular secondary interventions related to the device or treated pathology through 12 months.
Time Frame
12 months
Title
Absence of aneurysm expansion (> 5 mm diameter increase)
Description
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.
Time Frame
12 months
Title
Absence of stent-graft migration
Description
Primary effectiveness as measured by the absence of stent-graft migration (> 10 mm) through 12 months, compared to the first post-procedural CT.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Loss of stent-graft patency
Description
Loss of stent-graft patency will be assessed with CT scans, or MRIs for subjects unable to tolerate contrast media.
Time Frame
1 month and 6 months
Title
Rate of aneurysm rupture
Description
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.
Time Frame
1 month and 6 months
Title
Rate of endoleaks of all types
Description
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.
Time Frame
1 month, 6 months and 12 months
Title
Rate of stent fractures in the attachment zone
Description
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.
Time Frame
1 month and 6 months
Title
Incidence of open or endovascular secondary interventions
Description
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).
Time Frame
1 month and 6 months
Title
Rate of aneurysm expansion
Description
The rate of aneurysm expansion (> 5 mm diameter increase) assessed by comparison of follow-up imaging to the first post-procedural CT
Time Frame
1 month and 6 months
Title
Rate of stent-graft migration
Description
The rate of stent-graft migration (> 10 mm) assessed by comparison of follow-up imaging to the first post-procedural CT.
Time Frame
1 month and 6 months
Title
Individual outcomes of composite MAEs
Description
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.
Time Frame
6 months and 12 months
Title
Rate of vascular access complications
Description
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.
Time Frame
During the initial implant attempt
Title
Duration of implant procedure
Description
Duration of the initial implant procedure captured as the number of minutes from introduction of device to removal of delivery system.
Time Frame
Treatment Visit
Title
Number of blood transfusions
Description
Number of transfusions (units) required from the time of implant through hospital discharge.
Time Frame
Treatment Visit through Discharge Visit
Title
Duration of hospitalization
Description
Length of hospital stay defined as number of days subject was hospitalized for the initial implant procedure.
Time Frame
Treatment Visit through Discharge Visit
Title
Time in Intensive Care Unit (ICU)
Description
Duration of time in hours that subject was admitted to the Intensive Care Unit (ICU) following the implant procedure.
Time Frame
Treatment Visit through Discharge Visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilson Szeto, MD
Organizational Affiliation
Penn Presbyterian
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Venkatesh Ramaiah, MD
Organizational Affiliation
Arizona Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama-Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Heart Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Long Beach Memorial Hospital
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Indiana University Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
St. Vincent Heart Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
University of Iowa Hospital and Clinic
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Beth Israel Deaconess Medical Center / Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
East Carolina University Brody School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
University Hospitals
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania Medical Center / Penn Presbyterian
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Centennial Heart & Vascular Institute Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor Scott & White Medical Center - Plano The Heart Hospital
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Baylor Scot & White Medical Center - Temple
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Nagoya University Hospital
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Teine Keihinkai Hospital
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Nara Medical University Hospital
City
Kashihara
State/Province
Nara
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata City
State/Province
Niigata
Country
Japan
Facility Name
Oita University Hospital
City
Yufu City
State/Province
Oita
Country
Japan
Facility Name
Morinomiya Hospital
City
Joto-ku
State/Province
Osaka
Country
Japan
Facility Name
National Cerebral & Cardiovascular Center
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
Jichi Medical University Saitama Medical Center
City
Ōmiya
State/Province
Saitama
Country
Japan
Facility Name
Jikei University Hospital
City
Minato-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35241276
Citation
Szeto WY, Vallabhajosyula P, Matsuda H, Moainie SL, Sharafuddin MJ, Corvera J, Smolock CJ, Miyamoto S, Naslund T, Ramaiah V; RelayPro-A Investigators. One-year results with a low-profile endograft in subjects with thoracic aortic aneurysm and ulcer pathologies. J Thorac Cardiovasc Surg. 2022 May;163(5):1739-1750.e4. doi: 10.1016/j.jtcvs.2021.10.071. Epub 2022 Feb 1.
Results Reference
derived
Learn more about this trial
RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers
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