Study of the Relay Pro® Thoracic Stent-Graft in Subjects With Traumatic Injury of the Descending Thoracic Aorta

Bolton Medical

Status: Active, not recruiting

Conditions: Other Specified Injury of Thoracic Aorta

Treatments: Device: Relay Pro Thoracic Stent-Graft System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03090230

IP-0018-16

Details and patient eligibility

About

The purpose of this study is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with traumatic injury of the descending thoracic aorta (DTA)

Full description

This is a prospective, multicenter, non-blinded, non-randomized study of the RelayPro Thoracic Stent-Graft in subjects with traumatic injury of the DTA in subjects who are candidates for endovascular repair.The primary objective of the study is all-cause mortality at 30 days post procedure.

The secondary objectives of the trial will include descriptive analyses of procedural and post-procedural observations through 5 years of follow-up.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age greater than 18 years

• Subject must have a traumatic injury of the descending thoracic aorta that occurred no more than 30 days prior to the planned stent implant procedure

• Proximal and distal landing zones with diameter between 19 mm and 42 mm.

• Subject must have a proximal attachment zone distal to the left common carotid and a distal attachment zone proximal to the origin of the celiac artery.

• The length of the attachment zones will depend on the intended stent graft diameter.

  1. The proximal attachment zone should be: i. 15 mm for 22 - 28 mm grafts with bare stent (20 mm for RelayPro grafts with non-bare stent). ii. 20 mm for 30 - 46 mm grafts with bare stent (25 mm for RelayPro grafts with non-bare stent).
  2. The distal attachment zone should be 20 mm for all Relay Pro grafts.

• Coverage of the left subclavian artery is permitted. Revascularization of the left subclavian artery may be considered in all cases by the treating physician and, especially, in anatomies where revascularization is determined to be clinically necessary

• Proximal and distal attachment zones containing a straight segment (non-tapered, non-reverse tapered, defined by <10% diameter change) with lengths equal to or greater than the required attachment length for the intended device.

• Adequate iliac or femoral artery access for introduction of the RelayPro delivery system. Alternative methods to gain proper access may be utilized (e.g., iliac conduit).

• Subject willing to comply with the follow-up evaluation schedule.

• Subject (or Legally Authorized Representative, LAR) agrees to sign an Informed Consent Form prior to treatment

Exclusion criteria

• Significant stenosis, calcification, thrombus, or tortuosity of intended fixation sites that would compromise fixation or seal of the device.
• Planned coverage of left carotid or celiac arteries; or anatomic variants that may compromise circulation to the carotid, vertebral, or innominate arteries after device placement, and are not amenable to subclavian revascularization
• Prior endovascular or surgical repair in the DTA. The device may not be placed within any prior endovascular or surgical graft.
• Concomitant aneurysm/disease of the ascending aorta, aortic arch, or abdominal, aorta requiring repair.
• Prior abdominal aortic aneurysm repair (endovascular or surgical) that was performed less than 6 months prior to the planned stent implant procedure.
• Untreatable allergy or sensitivity to contrast media or device components.
• Known or suspected connective tissue disorder.
• Blood coagulation disorder or bleeding diathesis for which the treatment cannot be suspended for one week pre- and/or post-repair.
• Coronary artery disease with unstable angina.
• Severe congestive heart failure (New York Heart Association functional class IV).
• Stroke and/or Myocardial Infarction within 3 months of the planned treatment date.
• Pulmonary disease requiring the routine (daily or nightly) need for oxygen therapy outside the hospital setting.
• Acute renal failure or chronic renal insufficiency, and not receiving dialysis.
• Hemodynamically unstable.
• Active systemic infection and/or mycotic aneurysms.
• Morbid obesity or other condition that may compromise or prevent the necessary imaging requirements.
• Injury Severity Score of 75.
• Less than two-year life expectancy.
• Current or planned participation in an investigational drug or device study that has not completed primary endpoint evaluation.
• Currently pregnant or planning to become pregnant during the course of the study.
• Medical, social, or psychological issues that Investigator believes may interfere with treatment or follow-up.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Relay Pro Thoracic Stent-Graft System

Experimental group

Description:

The Relay Pro arm includes subjects who receive the device to treat traumatic injury of the descending thoracic aorta with the RelayPro Thoracic Stent-Graft System

Treatment:

Device: Relay Pro Thoracic Stent-Graft System