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Safety and Efficacy Study Comparing 3 New Types of Coronary Stents

NCT01166685 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2291

Last updated 2014-06-05

No results posted yet for this study

Summary

Background:

Retrospective analyses of long-term BASKET findings identified patients with large drug-eluting stents (DES) (\>2.5mm Stents) as patients at risk for late cardiac death/nonfatal myocardial infarction. In view of new DES with absorbable polymers and new bare metal stents BMS) with thin struts and biocompatible polymers, BP-II will be launched to test their comparative clinical safety up to 12 years if treated with an aspirin/prasugrel combination, since prasugrel halved stent thrombosis rates compared to clopidogrel in a large ACS trial.

The primary objective is to demonstrate non-inferiority of the Nobori DES stent compared to the Xience Prime DES stent on safety and e cacy in patients requiring stents \>=3.0mm in diameter on the background of contemporary dual antiplatelet therapy (DAPT) with prasugrel and aspirin

Set-up:

Multicenter open-label randomized trial.

Patient inclusion:

Unselected series of patients in need of large (\>3mm) stents only in native vessels irrespective of clinical indication.

Patient exclusion:

In-stent restenosis, Left-main disease, cardiogenic shock, planned surgery \<12months, increased bleeding risk, no compliance expected, History of stroke or transient ischemic attack (TIA).

Randomization:

By centre using sealed envelopes 1:1:1: Nobori:Xience Prime:Prokinetik-stent.

Conditions

Interventions

DEVICE

Everolimus-eluting stent

Everolimus-eluting stent

DEVICE

Bare-metal stent

Bare metal stent

DEVICE

Biodegradable Polymer-DES

drug-eluting stent with bioabsorbable polymer

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Christoph A Kaiser, Prof. MD · University Hospital Basel Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Austria
  • Denmark
  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01166685 on ClinicalTrials.gov