Clinical Trial: Trial of a Novel Paclitaxel-coated Balloon With Citrate Excipient for Restenosis in -Limus Analogue DES

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Trial of a Novel Paclitaxel-coated Balloon With Citrate Excipient for Restenosis in -Limus Analogue Drug-eluting Coronary Stents

Brief Summary:

Hypothesis:

Angioplasty with a novel paclitaxel-coated balloon (PCB; Agent, Boston Scientific) with citrate-based excipient will be non-inferior to conventional paclitaxel-coated balloon with iopromide excipient (PCB) for the treatment of coronary restenosis after implantation of limus-analogue drug-eluting stents (DES)


Detailed Summary: The optimal management of patients presenting with drug-eluting stent (DES) restenosis remains unclear. Data from recent randomized clinical trials have suggested that angioplasty with drug-coated balloons (DCB) is associated with excellent clinical outcomes. However, as the effectiveness of DCB devices depends critically on the specific composition of its matrix coating there may be important differences in clinical performance between different DCB devices. The prospective, non-randomized, single arm, historical-control ISAR-DESIRE 3A trial is designed to test that hypothesis that angioplasty with a novel paclitaxel-coated balloon with citrate-based excipient (Agent PCB, Boston Scientific) will be non-inferior to a conventional paclitaxel-coated balloon with iopromide excipient (SeQuent Please PCB, B. Braun; data from ISAR-DESIRE 3) for the treatment of coronary restenosis after implantation of limus-analogue drug-eluting stents (DES). The key inclusion criteria are patients with symptoms and/or objective signs of ischemia, restenosis at the site of previous limus-analogue DES implantation and written, informed consent. The primary endpoint is in-segment percent diameter stenosis (%DS) at 6-8 month follow-up angiography. Sample size calculation is based on a non-inferiority analysis: %DS of 35% after Both PCB, non-inferiority margin of 7% absolute, 1-sided α-level of 0.05 and power of 80% resulting in 102 patients per group. To account for possible FU losses 125 patients in total will be enrolled.
Sponsor: Deutsches Herzzentrum Muenchen

Current Primary Outcome: In-segment percent diameter stenosis (%DS) [ Time Frame: at 6-8 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • In-segment minimal lumen diameter and binary restenosis [ Time Frame: at 6-8 months ]
  • Composite of death or myocardial infarction [ Time Frame: at 12 months ]
  • Target lesion revascularization and thrombosis [ Time Frame: at 12 months ]


Original Secondary Outcome: Same as current

Information By: Deutsches Herzzentrum Muenchen

Dates:
Date Received: February 13, 2015
Date Started: January 2015
Date Completion: September 2017
Last Updated: November 18, 2016
Last Verified: November 2016