Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

CardioRoot Post-Marketing Surveillance Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Maquet Cardiovascular
Sponsor:
Information provided by (Responsible Party):
Maquet Cardiovascular
ClinicalTrials.gov Identifier:
NCT01609270
First received: May 25, 2012
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

Post-marketing surveillance registry of the CardioRoot graft.


Condition Intervention
Thoracic Aortic Surgery
Device: CardioRoot graft

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CardioRoot Post-Marketing Surveillance Registry

Further study details as provided by Maquet Cardiovascular:

Primary Outcome Measures:
  • Graft complications [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Complications will be assessed out to one year post implantation.


Secondary Outcome Measures:
  • Subject mortality rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Subject mortality rate will be followed out to one year post implantation.


Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CardioRoot
All subjects receive the CardioRoot graft at baseline implant procedure.
Device: CardioRoot graft
prospective single arm multi-center study to evaluate CardioRoot grafts implanted in a thoracic position.

Detailed Description:

Study objective is to monitor the performance and safety of CardioRoot vascular grafts implanted in a thoracic position. Patient survival rates will be monitored as well as immediate and long-term complications.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients requiring a CardioRoot graft as per the CardioRoot IFU

Exclusion Criteria:

  • patients with contra-indications per CardioRoot IFU
  • patients requiring consecutive aortic surgery
  • patients with coronary artery disease
  • patients who require urgent or emergent surgery
  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: NCT01609270

Contacts
Contact: Pierluca Lombardi, M.D. 973 709 7570 pierluca.lombardi@maquet.com

Locations
Czech Republic
Recruiting
Olomouc, Czech Republic
Recruiting
Prague, Czech Republic
France
Recruiting
Bordeaux, France
Italy
Recruiting
Grottaglie, Italy
Recruiting
Lecco, Italy
Sponsors and Collaborators
Maquet Cardiovascular
  More Information

No publications provided

Responsible Party: Maquet Cardiovascular
ClinicalTrials.gov Identifier: NCT01609270     History of Changes
Other Study ID Numbers: MCV00008317
Study First Received: May 25, 2012
Last Updated: October 20, 2014
Health Authority: Czech Republic: Ethics Committee
France: Committee for the Protection of Personnes
Germany: Ethics Commission
Italy: Ethics Committee

ClinicalTrials.gov processed this record on November 20, 2014