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

NCT01541410 | Completed Phase 1 DMC

• 1 other identifier: HYBRID-001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aneurysmal Disease of the Ascending Aorta, the Arch and the Proximal Descending Aorta

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

  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.

  ≤30 days

• Primary Effectiveness Endpoint

  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.

  ≤365 days

Secondary Outcomes (2)

• Technical Success

  Pre-discharge, 6 and 12 months

• Assessment of Stent Graft Migration and Integrity

  Pre-discharge, 6 and 12 months

Interventions

Vascutek Hybrid Graft DEVICE

Single Group Assignment

Eligibility Criteria

• Age: 29 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients unfit for open surgical repair involving circulatory arrest
• Endocarditis or active infective disorder of the aorta
• Patients unwilling to give informed consent

Sponsors & Collaborators

• Vascutek Ltd.: lead

Study Sites (1)

Division of Thoracic and Cardiovascular Surgery, Hannover Medical School

Hanover, 30625, Germany

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2012
• First Posted: March 1, 2012
• Study Start: May 1, 2010
• Primary Completion: August 1, 2011
• Last Updated: July 15, 2013

Record last verified: 2013-07

Locations

DE (1)