NCT03414866

Thoraflex Hybrid Post-Market Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 182 (actual)
• Sponsor: Vascutek Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a global, prospective non-interventional, multi-centre, post-market study of the Vascutek Thoraflex™ Hybrid system in patients with acute thoracic aortic syndrome, subacute/chronic dissection of the aorta and aortic aneurysm.

Detailed description

Aortic arch pathologies are rare, but pose significant challenges for treatment involving open surgical or endovascular repair. In 1983 the Elephant Trunk technique was introduced and has greatly facilitated the management of patients with extensive thoracic aortic disease. In recent years, this traditional open surgery has been combined with thoracic endovascular repair (TEVAR) and this is known as the 'hybrid' approach. Hybrid repairs, consisting of an open surgical repair combined with endovascular techniques. Further advancement in the types of prosthesis available has resulted in the evolution of the conventional ET technique into the frozen elephant trunk (FET) technique. This utilises devices that incorporate both a traditional dacron graft (for open surgical treatment of the aortic arch) and a stented graft portion (for treatment of the descending thoracic aorta). The stented portion of the graft is introduced via an antegrade approach through the transected arch. The FET technique is now commonly used to treat patients with extensive thoracic or thoraco-abdominal aortic disease. Vascutek Ltd has developed the Thoraflex™ Hybrid Device (Plexus™ 4 and Ante-Flo™) for the repair or replacement of damaged or diseased vessels of the ascending aorta, aortic arch and descending thoracic aorta in cases of aneurysm and/or dissection. The Thoraflex™ Hybrid Device is one of the commercially available frozen elephant trunk prosthesis. Over 3000 Thoraflex™ Hybrid Devices have been sold and the current study seeks to provide further evidence of the continuing safety and effectiveness of the device.

Conditions

• Acute Aortic Dissection
• Aortic Rupture
• Penetrating Aortic Ulcer
• Aortic Dissection
• Aortic Aneurysm, Thoracic

Interventions

Type	Name	Description
BEHAVIORAL	EQ-5D-5L QOL questionnaire	Written questionnaire

Timeline

• Start date: 2018-05-25
• Primary completion: 2025-04-25
• Completion: 2026-07-01
• First posted: 2018-01-30
• Last updated: 2025-07-09

Locations

7 sites across 4 countries: Canada, Germany, Italy, Netherlands