Clinical trial NCT02818972: RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Aneurysm, Thoracic
Penetrating Ulcer
Lead sponsor: Bolton Medical
Sponsor class: INDUSTRY
First posted: 2016-06-30
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Rate of Major Adverse Events (MAEs)
timeFrame: 30 days
measure: Technical success
timeFrame: 24 hours
measure: Stent graft patency
timeFrame: 12 months
measure: Aneurysm rupture
timeFrame: 12 months
measure: Absence of Type I and III endoleak through 12 months;
timeFrame: 12 months
measure: Absence of stent fractures in the attachment zone through 12 months
timeFrame: 12 months
measure: Absence of open or endovascular secondary interventions
timeFrame: 12 months
measure: Absence of aneurysm expansion (> 5 mm diameter increase)
timeFrame: 12 months
measure: Absence of stent-graft migration
timeFrame: 12 months
Secondary outcomes:
measure: Loss of stent-graft patency
timeFrame: 1 month and 6 months
measure: Rate of aneurysm rupture
timeFrame: 1 month and 6 months
measure: Rate of endoleaks of all types
timeFrame: 1 month, 6 months and 12 months
measure: Rate of stent fractures in the attachment zone
timeFrame: 1 month and 6 months
measure: Incidence of open or endovascular secondary interventions
timeFrame: 1 month and 6 months
measure: Rate of aneurysm expansion
timeFrame: 1 month and 6 months
measure: Rate of stent-graft migration
timeFrame: 1 month and 6 months
measure: Individual outcomes of composite MAEs
timeFrame: 6 months and 12 months
measure: Rate of vascular access complications
timeFrame: During the initial implant attempt
measure: Duration of implant procedure
timeFrame: Treatment Visit
measure: Number of blood transfusions
timeFrame: Treatment Visit through Discharge Visit
measure: Duration of hospitalization
timeFrame: Treatment Visit through Discharge Visit
measure: Time in Intensive Care Unit (ICU)
timeFrame: Treatment Visit through Discharge Visit
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama-Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Arizona Heart Institute
state: Arizona
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Hospital
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Heart Center
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinic
state: Iowa
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center / Harvard Medical School
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Medical Center / Penn Presbyterian
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Centennial Heart & Vascular Institute Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Plano
country: United States
facility: Baylor Scott & White Medical Center - Plano The Heart Hospital
state: Texas
city: Temple
country: United States
facility: Baylor Scot & White Medical Center - Temple
state: Texas
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Sapporo
country: Japan
facility: Teine Keihinkai Hospital
state: Hokkaido
city: Kashihara
country: Japan
facility: Nara Medical University Hospital
state: Nara
city: Niigata City
country: Japan
facility: Niigata University Medical & Dental Hospital
state: Niigata
city: Yufu City
country: Japan
facility: Oita University Hospital
state: Oita
city: Joto-ku
country: Japan
facility: Morinomiya Hospital
state: Osaka
city: Suita
country: Japan
facility: National Cerebral & Cardiovascular Center
state: Osaka
city: Ōmiya
country: Japan
facility: Jichi Medical University Saitama Medical Center
state: Saitama
city: Minato-Ku
country: Japan
facility: Jikei University Hospital
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
Study officials:
affiliation: Penn Presbyterian
name: Wilson Szeto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arizona Heart Institute
name: Venkatesh Ramaiah, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.