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

Aortic Aneurysm, Thoracic Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02818972
• Other study ID #: IP-0015-16
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 10, 2017
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: Bolton Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: June 2024
• Est. primary completion date: June 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Penetrating Ulcer
• Ulcer

Intervention

Device:
• RelayPro
Endovascular treatment with investigational device.

Locations

Country	Name	City	State
Japan	Hiroshima University Hospital	Hiroshima
Japan	Morinomiya Hospital	Joto-ku	Osaka
Japan	Nara Medical University Hospital	Kashihara	Nara
Japan	Jikei University Hospital	Minato-Ku	Tokyo
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	Niigata University Medical & Dental Hospital	Niigata City	Niigata
Japan	Jichi Medical University Saitama Medical Center	Omiya	Saitama
Japan	Teine Keihinkai Hospital	Sapporo	Hokkaido
Japan	Keio University Hospital	Shinjuku-Ku	Tokyo
Japan	National Cerebral & Cardiovascular Center	Suita	Osaka
Japan	Oita University Hospital	Yufu City	Oita
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	University of Alabama-Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center / Harvard Medical School	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University Hospitals	Cleveland	Ohio
United States	University of Texas Southwestern	Dallas	Texas
United States	University of Florida	Gainesville	Florida
United States	Hartford Hospital	Hartford	Connecticut
United States	Indiana University Health	Indianapolis	Indiana
United States	St. Vincent Heart Center	Indianapolis	Indiana
United States	University of Iowa Hospital and Clinic	Iowa City	Iowa
United States	University of California, Irvine	Irvine	California
United States	Long Beach Memorial Hospital	Long Beach	California
United States	Centennial Heart & Vascular Institute Sarah Cannon Research Institute	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	University of Pennsylvania Medical Center / Penn Presbyterian	Philadelphia	Pennsylvania
United States	Arizona Heart Institute	Phoenix	Arizona
United States	Baylor Scott & White Medical Center - Plano The Heart Hospital	Plano	Texas
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Baylor Scot & White Medical Center - Temple	Temple	Texas
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bolton Medical

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	30 days
Primary	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.	24 hours
Primary	Stent graft patency	Primary effectiveness as measured by the rate of stent-graft patency through 12 months.	12 months
Primary	Aneurysm rupture	Primary effectiveness as measured by the absence of aneurysm rupture through 12 months.	12 months
Primary	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.	12 months
Primary	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.	12 months
Primary	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.	12 months
Primary	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.	12 months
Primary	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.	12 months
Secondary	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.	1 month and 6 months
Secondary	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.	1 month and 6 months
Secondary	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.	1 month, 6 months and 12 months
Secondary	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.	1 month and 6 months
Secondary	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).	1 month and 6 months
Secondary	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	1 month and 6 months
Secondary	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.	1 month and 6 months
Secondary	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.	6 months and 12 months
Secondary	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.	During the initial implant attempt
Secondary	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.	Treatment Visit
Secondary	Number of blood transfusions	Number of transfusions (units) required from the time of implant through hospital discharge.	Treatment Visit through Discharge Visit
Secondary	Duration of hospitalization	Length of hospital stay defined as number of days subject was hospitalized for the initial implant procedure.	Treatment Visit through Discharge Visit
Secondary	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.	Treatment Visit through Discharge Visit