Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Thoracic Aortic Aneurysms and Chronic Dissections
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Aneurysm, Thoracic
- Sponsor
- University Hospital, Toulouse
- Locations
- 2
- Primary Endpoint
- Safety events (aorta related mortality, stroke, paraplegia, left arm/hand ischemia)
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
Brief Summary
To ensure adequate seal of currently available stent grafts, a proximal 20 mm of healthy aorta is recommended. Extending the proximal landing zone into the arch by intentional covering of the left subclavian artery (LSA) without revascularization expose to serious neurologic complications. Serious risks are also known to accompany subclavian revascularization. The Valiant Mona LSA Thoracic Stent Graft System (Medtronic,Santa Rosa, Calif) consists of a main stent graft and a branch stent graft designed to maintain LSA patency. The purpose of this study is to characterize the safety and effectiveness of this device for the treatment of Aneurysms and chronic Type B dissections of the arch.
Detailed Description
Stent graft coverage of the left subclavian artery (LSA) may be required to achieve an adequate landing zone in up to 40% of descending thoracic aneurysms (DTAs). To ensure adequate seal of currently available off-the-shelf stent grafts, 20 mm of healthy aorta is recommended between the proximal neck of the aneurysm and the leading edge of the stent graft. Stent graft placement can be facilitated by extending the proximal landing zone into the arch and covering the LSA; however, there may be a higher risk of serious neurologic outcomes (cerebral and paraplegia), although this is still a matter of debate. Serious risks are also known to accompany subclavian revascularization, which may involve bypass or transposition. The Valiant Mona LSA Thoracic Stent Graft System (Medtronic,Santa Rosa, Calif) consists of a main stent graft and a branch stent graft designed to maintain LSA patency while diverting circulation through the encroaching aneurysm. The purpose of the feasibility study is to characterize the safety of the Valiant Mona LSA Thoracic Stent Graft System, including an assessment of the safety and effectiveness of the device acutely and at the 1-month visit in the identified subject population (Aneurysms and chronic, Type B dissections). A follow up of this population will be annually during 5 years. This pilot, non-randomized, single-arm prospective study will concern 20 patients. Inclusion criteria required patients with a thoracic aortic aneurysm (TAA) or dissection with an indication of a stent-Graft insertion. Primary end points will be aneurysm-related mortality, stroke, paraplegia, left arm/hand ischemia, and treatment success. Technical success will be assessed by imaging at 1 month, 6 months then annually during 5 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is at least 18 years of age.
- •Subject understands and has signed an Informed Consent
- •Subject must be considered a candidate for revascularization of the LSA.
- •Subject must be able to tolerate a surgical revascularization of the LSA.
- •Subject has a descending thoracic aneurysm (DTA) which will require coverage of the LSA
- •Subject has a healthy, non-diseased aortic proximal seal zone of at least 10 mm from the left carotid to the LSA and at least 5 mm landing zone distal to the LSA and proximal to the start of the aneurysm/ulcer/or the proximal entry tear for dissection.
- •Subject has a non-diseased aortic diameter between 25 mm and 42 mm (fusiform/saccular aneurysms or penetrating ulcers) or 28 mm to 44 mm (chronic type B dissections),
- •Subject has a LSA with a diameter between 8 mm and 13 mm.
- •Subject has sufficient landing zone within the LSA to accommodate the BSG without occlusion of any significant vessels
- •Subject has patent brachial arteries, iliac or femoral arteries (without circumferential calcifications and a diameter of ≥ 10mm), or can tolerate a conduit that will allow endovascular access to the aneurysmal site with the delivery system of the appropriate sized device chosen for treatment.
Exclusion Criteria
- •Subject has an aneurysmal, tortuous, or atherosclerotic LSA, conflicting the branch graft insertion.
- •Subject has an aortic atheroma classified as grade IV or grade V.
- •Subject has prohibitive calcification, occlusive disease, or tortuosity of intended fixation sites.
- •Treatment with the Valiant Mona LSA Thoracic Stent Graft system would require intentional coverage of the left common carotid artery with the stent graft fabric.
- •Subject has significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment sites that would compromise fixation and seal of the device.
- •Subject is a pregnant or breastfeeding female.
- •Subject has a known allergy or intolerance to the device components.
- •Subject is in acute renal failure or has renal insufficiency with a serum creatinine ≥ 2.0 mg/dL or is on dialysis.
- •Subject has coronary artery disease with unstable angina and has not received treatment.
- •Subject has a connective tissue disease (e.g. Marfan's syndrome, medial degeneration).
Outcomes
Primary Outcomes
Safety events (aorta related mortality, stroke, paraplegia, left arm/hand ischemia)
Time Frame: 1 month
Composite endpoint defined as the occurrence of one of the following events: aorta related mortality, stroke, paraplegia, left arm/hand ischemia
Effectiveness
Time Frame: 1 month
Effectiveness defined as technical success and successful exclusion of the aneurysm or false lumen while maintaining patency of the main stent graft (MSG) and branch stent graft (BSG)
Secondary Outcomes
- Characteristics of the intervention (blood loss)(Day 0)
- Aorta related mortality(6 months, 12 months, 24 months, 36 months, 48 months and 60 months)
- Effectiveness (Successful exclusion of the aneurysm)(6 months, 12 months, 24 months, 36 months, 48 months and 60 months)
- Effectiveness (patency)(6 months, 12 months, 24 months, 36 months, 48 months and 60 months)
- Necessary time for the branch placement(Day 0)
- Characteristics of the intervention (general anaesthesia)(Day 0)
- Duration of the hospitalization(Day 0)
- Characteristics of the hospitalization (intraoperative complications)(Day 0)
- Stroke(6 months, 12 months, 24 months, 36 months, 48 months and 60 months)
- Paraplegia(6 months, 12 months, 24 months, 36 months, 48 months and 60 months)
- Left arm/hand ischemia(6 months, 12 months, 24 months, 36 months, 48 months and 60 months)
- Duration of the intervention(Day 0)
- Quality of life with EuroQol-5D(Baseline, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months)
- Minor adverse events(1 month, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months)
- Characteristics of the intervention (transfusion)(Day 0)
- Duration of the stay in intensive care(Day 0)
- Serious adverse events(1 month, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months)