A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With an Acute, Complicated Type B Aortic Dissection
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Aortic Dissection Type B
- Sponsor
- Bolton Medical
- Enrollment
- 56
- Locations
- 21
- Primary Endpoint
- All-cause mortality post-procedure
- Status
- Active, Not Recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B aortic dissection. The primary endpoint will measure all-cause mortality at 30 days post-procedure.
Detailed Description
This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B aortic dissection. The primary endpoint will measure all-cause mortality at 30 days post-procedure. Subjects will be enrolled on a first come, first serve basis; however, no single investigational site may enroll more than 20% of the proposed sample size of up to 80 subjects. A subject is considered enrolled when arterial access is gained and an attempt is made to introduce the RelayPro Thoracic Stent-Graft. Enrollment is expected to begin in mid-2016 and complete by the end of 2020. All subjects enrolled, as defined above, will be included in the patient population for the primary safety analyses. All subjects implanted with the RelayPro Thoracic Stent-Graft will be included in the patient population for the primary effectiveness analyses.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject must have an acute (symptom onset to diagnosis within 2 weeks)or subacute, complicated type B aortic dissection (entire dissection is distal to the left subclavian artery (LSA)), confirmed by Computed Tomography Angiography (CTA) or Magnetic Resonance Angiogram (MRA), with time from symptom onset to diagnosis ≤ 6 weeks, with at least one of the following:
- •Malperfusion of the viscera, kidneys, spinal cord, or lower extremities, measured by clinical or radiographic evidence;
- •Intractable pain.
- •Proximal and distal aortic neck with diameter between 19 mm and 42 mm.
- •Subject's anatomy must meet all of the following anatomical criteria:
- •Proximal attachment zone distal to the left common carotid and a distal attachment zone proximal to the origin of the celiac artery. (Dissection is permitted in the distal attachment zone but is not permitted in the proximal attachment zone.)
- •The length of the attachment zones will depend on the intended stent-graft diameter and type of graft selected.
- •The proximal attachment zone should be 15 mm for 22 - 28 mm RelayPro grafts with bare stent (20 mm for RelayPro grafts with non-bare stent), 20 mm for 30 - 46 mm RelayPro grafts with bare stent (25 mm for RelayPro grafts with non-bare stent), and proximal to non-dissected segment (healthy zone).
- •The distal attachment zone should be 20 mm for all RelayPro grafts.
- •Coverage of the left subclavian artery is permitted with mandatory revascularization if patent left internal mammary artery (LIMA) bypass or left upper extremity (LUE) arteriovenous graft or anomalous vertebral artery off the aorta. Revascularization must be performed prior to device placement, and may occur during implant procedure, provided it is before coverage of the LSA by the endograft.
Exclusion Criteria
- •Diagnosis of traumatic injury or transection of the descending thoracic aorta.
- •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 would compromise circulation to the carotid, vertebral, or innominate arteries after device placement, which is not amenable to subclavian revascularization.
- •Prior endovascular or surgical repair in the descending thoracic aorta. 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. Dissection extension into the abdominal aorta is acceptable.
- •Prior abdominal aortic aneurysm repair (endovascular or surgical) that was performed less than 6 months prior to the planned stent implant procedure.
- •Major surgical or medical procedure within 30 days prior to the planned procedure, or is scheduled for a major surgical or medical procedure within 30 days post implantation. This excludes any planned procedures for the prospective stent-graft placement.
- •Untreatable allergy or sensitivity to contrast media or device components, including metal stents.
- •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.
Outcomes
Primary Outcomes
All-cause mortality post-procedure
Time Frame: 30 days
All-cause mortality 30 days post-procedure
Secondary Outcomes
- Technical Success at the time of the index procedure(During deployment of the device)
- Treatment success through 1 month(1 month, 6 months, 12 months, and annually through 5 years, defined as individual endpoints and as a composite)
- Dissection Treatment Success(1, 6, and 12 month follow-up visits, and annually through 5 years.)