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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vascutek Ltd.
ClinicalTrials.gov Identifier:
NCT01541410
First received: February 13, 2012
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Aneurysmal Disease of the Ascending Aorta, the Arch and the Proximal Descending Aorta
Device: Vascutek Hybrid Graft
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Vascutek Ltd.:

Primary Outcome Measures:
  • Primary Safety Endpoint [ Time Frame: ≤30 days ] [ Designated as safety issue: Yes ]
    The primary safety endpoint will be the proportion of subjects free from paraplegia, secondary conversion to conventional open surgical repair and death due to device or procedure related complications ≤30 days post-procedure.

  • Primary Effectiveness Endpoint [ Time Frame: ≤365 days ] [ Designated as safety issue: No ]
    The primary effectiveness endpoint will be successful aneurysm treatment, defined as a composite endpoint of subjects who have successful delivery and deployment of the Vascutek Hybrid Device at the initial procedure and at ≤365 days post-procedure.


Secondary Outcome Measures:
  • Technical Success [ Time Frame: Pre-discharge, 6 and 12 months ] [ Designated as safety issue: No ]
    Technical success is defined as the placement and deployment of a Vascutek Hybrid Device in the absence of mortality, conversion to conventional open surgical repair, failed patency, evidence of an unanticipated distal type I or a type III endoleak on pre-discharge CT scan.

  • Assessment of Stent Graft Migration and Integrity [ Time Frame: Pre-discharge, 6 and 12 months ] [ Designated as safety issue: No ]
    Stent graft migration will be defined as stent graft migration in excess of 10mm which requires secondary intervention. Structural integrity will be assessed primarily from plain x-ray and CT scan images and will be represented in binomial fashion.


Enrollment: 34
Study Start Date: May 2010
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Vascutek Hybrid Graft
    Single Group Assignment
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.

  Eligibility

Ages Eligible for Study:   29 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with aneurysm and/or dissection of the aortic arch and/or descending aorta
  2. Patient must have agreed to participate voluntarily and have signed and dated an Ethics Committee approved Patient Informed Consent
  3. Patient is able and willing to comply with the protocol and associated follow-up requirements

Exclusion Criteria:

  1. Patients unfit for open surgical repair involving circulatory arrest
  2. Endocarditis or active infective disorder of the aorta
  3. Patients unwilling to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541410

Locations
Germany
Division of Thoracic and Cardiovascular Surgery, Hannover Medical School
Hannover, Germany, 30625
Sponsors and Collaborators
Vascutek Ltd.
  More Information

No publications provided

Responsible Party: Vascutek Ltd.
ClinicalTrials.gov Identifier: NCT01541410     History of Changes
Other Study ID Numbers: HYBRID-001
Study First Received: February 13, 2012
Last Updated: July 12, 2013
Health Authority: Germany: German Institute of Medical Documentation and Information

ClinicalTrials.gov processed this record on July 22, 2014