Clinical Trial: Paclitaxel Eluting Balloon Versus Drug Eluting Stent in Native Coronary Artery Stenoses of Diabetic Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Paclitaxel-Eluting Balloon Angioplasty and Cobalt-Chromium Stents Versus Conventional Angioplasty and Paclitaxel-Eluting Stents in the Treatment of Native Coronary Artery Stenose

Brief Summary:

The aim of the study is to compare the efficacy of Paclitaxel-eluting PTCA-balloon dilation (SeQuentTM Please) followed by cobalt-chromium stent (CoroflexTM Blue) deployment versus Paclitaxel-eluting stent (TaxusTM LibertéTM) deployment in the treatment of de-novo-stenoses in native coronary arteries (reference diameter:more then 2.5 mm and below 3.5 mm, length of stenosis ≥ 10 mm ≤ 20 mm) of patients with diabetes mellitus for ≥ 3 years for procedural success and preservation of vessel patency.

This study is a prospective, randomized, multi-center, two-armed phase-II pilot study conducted in Malaysia and Thailand.

128 diabetes mellitus patients shall complete the study per protocol after random assignment to either of the treatment groups on the order of 20 to 50 patients per center.

Diabetes mellitus patients with stable or selected forms of unstable angina or documented ischemia due to a de-novo stenosis in a native coronary artery will be enrolled. Vessels may not supply an entirely infarcted myocardial area.

Late lumen loss at 9 months is the primary endpoint.


Detailed Summary:
Sponsor: Heart Centre Rotenburg

Current Primary Outcome: Late lumen loss at 9 months [ Time Frame: 9 months ]

Original Primary Outcome: Late lumen loss at 9 months

Current Secondary Outcome:

  • Procedural success [ Time Frame: during procedure ]
  • Occurrence of acute (up to 48 hours), subacute (up to 30 days), and late thrombosis [ Time Frame: 3 years ]
  • 30-day MACE rate [ Time Frame: 30 days ]
  • Percent in-stent stenosis at 9 months [ Time Frame: 9 months ]
  • Percent in-segment stenosis at 9 months [ Time Frame: 9 months ]
  • In-stent late loss index at 9 months [ Time Frame: 9 months ]
  • Angiographic binary in-stent stenosis rate at 9 months [ Time Frame: 9 months ]
  • In-segment late loss index at 9 months [ Time Frame: 9 months ]
  • Angiographic binary in-segment stenosis rate at 9 months [ Time Frame: 9 months ]
  • Acute and cumulative MACE rate at 9 months [ Time Frame: 9 months ]
  • Cumulative MACE rate after 2 years [ Time Frame: 2 years ]
  • Indication for premature follow-up [ Time Frame: up to 9 months ]
  • Type of recurrence (Mehran-Classification) [ Time Frame: 9 months ]
  • Target vessel failure [ Time Frame: 9 months ]


Original Secondary Outcome:

  • Procedural success
  • Occurrence of acute (up to 48 hours), subacute (up to 30 days), and late thrombosis
  • 30-day MACE rate
  • Percent in-stent stenosis at 9 months
  • Percent in-segment stenosis at 9 months
  • In-stent late loss index at 9 months
  • Angiographic binary in-stent stenosis rate at 9 months
  • In-segment late loss index at 9 months
  • Angiographic binary in-segment stenosis rate at 9 months
  • Acute and cumulative MACE rate at 9 months
  • Cumulative MACE rate after 2 years
  • Indication for premature follow-up
  • Type of recurrence (Mehran-Classification)
  • Target vessel failure


Information By: Heart Centre Rotenburg

Dates:
Date Received: April 18, 2007
Date Started: May 2007
Date Completion:
Last Updated: February 18, 2016
Last Verified: February 2016