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

Bolton Medical

Status: Active, not recruiting

Conditions: Penetrating Ulcer; Aortic Aneurysm, Thoracic

Treatments: Device: RelayPro

Study type: Interventional

Funder types: Industry

Identifiers

NCT02818972

IP-0015-16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

RelayPro

Experimental group

Description:

Endovascular treatment with the investigational device.

Treatment:

Device: RelayPro