Clinical Trial: Feasibility Study of ANEUFIX: a Novel Approach to Treat Type II Endoleaks Using ACP-T5

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Feasibility Study of ANEUFIX: a Novel Approach to Treat Type II Endoleaks Using ACP-T5

Brief Summary: The study is a non-randomized, multi-center safety and feasibility trial of Aneufix ACP-T5 to treat patients with Isolated type II endoleak in the presence of a non-shrinking AAA sac following an EVAR procedure.

Detailed Summary: The investigational device is called Aneufix, more specifically the model ACP-T5, which is a product treating the endoleak by blockage of backflowing blood vessels, i.e. by filling the 'endoleak void and nidus of feeding artery and exit of existing draining arteries'.
Sponsor: TripleMed B.V.

Current Primary Outcome: Technical success of Type II endoleak repair with Aneufix ACP-T5 as demonstrated by the absence of an endoleak at the end of the procedure. [ Time Frame: 24h ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: TripleMed B.V.

Dates:
Date Received: June 29, 2015
Date Started: August 2015
Date Completion: December 2015
Last Updated: June 29, 2015
Last Verified: June 2015