Valiant Mona LSA Thoracic Stent Graft Early Feasibility Study

• Research type

  Research Study

• Full title

  Prospective, nonrandomized, three-center, pre-market clinical study evaluating subjects implanted with the Valiant Mona LSA Thoracic Stent Graft System for the treatment of descending thoracic aneurysms that are candidates for revascularization of the left subclavian artery (LSA).

• IRAS ID

  137086

• Contact name

  Matthew Merfyn Thompson

• Contact email

  matt.thompson@stgeorges.nhs.uk

• Sponsor organisation

  Medtronic Vascular

• Clinicaltrials.gov Identifier

  NCT01839695

• Research summary

  A descending thoracic aneurysm (DTA) is a life-threatening condition. There is a risk of progressive enlargement and rupture, which is almost invariably fatal. Current available treatment options include open surgical repair and endovascular stent graft repair. Commercially available thoracic stent grafts for DTA require lengthy proximal landing zones to ensure adequate seal to healthy aorta. As many as 40% of thoracic endovascular aortic repair (TEVAR) patients do not meet this criteria. In these cases, consideration is given to whether covering the patient’s LSA with the fabric portion of a stent graft lengthens the proximal landing zone. If the LSA is covered, consideration is given whether or not to revascularize the LSA. The US Society for Vascular Surgery (SVS) recommends preoperative revascularization in all of these patients. However, LSA revascularization is not without risks and despite the SVS practice guidelines, some physicians decide not to perform LSA revascularization.

  The Valiant Mona LSA Thoracic Stent Graft System is a single branch device for repair of DTA which preserves patency of the LSA. This device will help expand patient applicability for TEVAR and improve patient outcomes by preserving the LSA.
  This study of the Valiant Mona LSA Stent Graft System System is an Early Feasibility Study and will enroll 10 subjects with DTA who are candidates for endovascular repair and prospective coverage of the LSA. Three sites will recruit subjects: 2 in USA and one in UK (St George's Vascular Institute). Subjects will be discharged, followed up at 1, 6 & 12 months and annually to five years.

  The data collected will assess safety and performance acutely and at 30 days. At this time, the data collected is not intended to be used to support CE Mark of this investigational device. The intent of this early feasibility study will be only to validate the device design, evaluate patient characteristics, and applicability.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  13/LO/1424

• Date of REC Opinion

  4 Dec 2013

• REC opinion

  Further Information Favourable Opinion