Evaluation of the Vascutek Hybrid Graft for Use in the Replacement of the Aortic Arch and Concomitant Treatment of an Aneurysm/Dissection of the Descending Aorta in the Frozen Elephant Trunk Procedure
Condition: Aneurysmal Disease of the Ascending Aorta, the Arch and the Proximal Descending Aorta
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this feasibility study is to investigate the clinical performance of the
      Vascutek Hybrid Device in the treatment of subjects with aneurysm and/or dissection of the
      thoracic aorta.
    

Detailed description: 
      The Vascutek Hybrid device is designed for use during a frozen elephant trunk procedure. Each
      system is comprised of a fully sealed traditional prosthesis which is stented at the distal
      end. A minimum of 10 and a maximum of 30 patients with aneurysmal disease of the ascending
      aorta, the arch and the proximal descending aorta will receive a hybrid prosthesis implanted
      without the use of the delivery system and a minimum of 10 patients and a maximum of 20
      patients will be implanted with a hybrid device using the delivery system.

      The traditional prosthesis component is representative of current Gelweave™ product. It is a
      woven polyester graft, crimped to maintain the lumen and gel coated to ensure that it will
      seal immediately. The stented section of the graft is a self-expanding endoprosthesis
      constructed of a thin wall woven polyester and Nitinol ring stents, which are attached to
      fabric with braided polyester sutures.

      The delivery system is a central catheter comprised of a stainless steel braided,
      Isoplast-Pebax co-extrusion which has been locally strengthened to provide adequate guidewire
      lumen and sufficient stiffness to deploy the device. The outer sheath is 24Fr extruded PTFE
      with a groove to provide a localised splitting during deployment. The handle components are
      moulded in K-Resin & thermoplastic polyurethane to fulfil the functional requirements of the
      product.

      The compacted endoprosthesis is placed through the opened aortic arch and deployed leaving
      the stented section positioned inside the descending aorta. The device is then released from
      the delivery system and the handle components removed leaving the full graft in situ and
      correctly positioned. This allows the surgeon to complete the aortic arch repair as required.

      The materials of the endoprosthesis section, and of the traditional prosthesis section of the
      Hybrid Device are identical to those of current Vascutek product (Anaconda™ Stent Graft
      System - endoprosthesis; and Gelweave™ - standard vascular graft). All materials used in the
      delivery system are well established in medical applications.

      The Vascutek Ltd. Hybrid Device is produced using established manufacturing and Quality
      Control methodologies in an ISO 9001 and ISO 13485 certified system. The Hybrid Device is
      provided sterile for single use only. The method of sterilisation is ethylene oxide.
    

Intervention name(s): Vascutek Hybrid Graft
Intervention type(s): Device
Intervention description(s): Single Group Assignment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment