Prospective, Multi-Center, Random. Study of CoStar Paclitaxel-Eluting Coronary Stent(Direct Stenting vs. Pre-Dilatation) (DECIDE)

October 29, 2009 updated by: Conor Medsystems

The DECIDE Trial: Prospective, Multi-center, Randomized Study to Evaluate the CoStar Paclitaxel-Eluting Coronary Stent System Using a Direct Stenting Technique Compared to Conventional Stenting With Pre-dilatation Strategy

The primary objective of this study is to evaluate the safety and effectiveness of a direct stenting technique compared to conventional stenting with pre-dilatation strategy using the CoStar Paclitaxel-eluting coronary stent system for the treatment of a single de novo lesion in a native coronary artery ≤ 25 mm long in a native coronary artery 2.5-3.5 mm diameter.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Prospective, multi-center, randomized (1:1), open-label study to evaluate direct stenting compared to conventional stenting with pre-dilatation strategy in treatment of a single de novo Lesion of a single native coronary artery in patients undergoing elective percutaneous coronary intervention.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, D-22527
        • Universitäres Herz-und Gefäßzentrum Hamburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Eligible for percutaneous coronary intervention
  • Documented stable or unstable angina pectoris or with documented ischemia, or with documented silent ischemia
  • Left ventricular ejection fraction (LVEF) ≥25% documented within the last 6 weeks
  • Acceptable candidate for coronary artery bypass graft surgery
  • Single target vessel / single target lesion to be treated
  • Target lesion may be composed of multiple lesions but must be completely coverable by one (1) study stent
  • Cumulative target lesion length per vessel is ≤ 25 mm
  • RVD of 2.5-3.5 mm
  • Target lesion diameter stenosis ≥ 50% and < 100%
  • Target vessel has not undergone prior revascularization within the preceding 6 months

Exclusion Criteria:

  • Known sensitivity to cobalt chromium, Paclitaxel or PLGA
  • Acute MI within 72 hours prior to the index procedure as defined by the presence of a new pathologic Q-wave, or a creatine kinase (CK) level of > 2x the laboratory upper limits of normal and elevated MB
  • The patient is in cardiogenic shock
  • Cerebrovascular Accident (CVA) within the past 6 months
  • Acute or chronic renal dysfunction (creatinine > 2.0 mg/dL or > 150 µmol/L)/
  • Contraindication to ASA or to Clopidogrel
  • Thrombocytopenia (platelet count <100,000/mm3)
  • Active gastrointestinal (GI) bleeding within the past three months
  • Any prior true anaphylactic reaction to contrast agents
  • Patient is currently taking Colchicine
  • Patient is currently, or has been treated with Paclitaxel (systemic) within12 months of the index procedure
  • Comorbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
  • Left main coronary artery disease (stenosis >50%), whether protected or unprotected.
  • Target lesion involves a bifurcation with a diseased (>50% stenotic) branch vessel >2.0 mm in diameter that requires intervention.
  • Target lesion is totally occluded Thrombolysis In MI (TIMI flow ≤1).
  • The target vessel has had prior drug-eluting stent placement to vessel segment (or branch) proximal to intended target lesion site.
  • Angiographic restenosis of any segment of the target vessel that has undergone prior PCI.
  • Angiographic evidence of atherosclerotic disease with >50% diameter stenosis (by visual estimate) proximal or distal to the target lesion (applies to the major epicardial portion of the target vessel and contiguous vessel segment if the target lesion is located in a branch vessel)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Direct stenting technique
Device: CoStar Paclitaxel-eluting coronary stent system
Experimental: 2
Conventional stenting with pre-dilatation strategy
Device: CoStar Paclitaxel-eluting coronary stent system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adjudicated MACE at 30 days
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Primary & second. device success, Lesion and Procedure success, Adjudicated MACE 8, 9, 12, 24 mos post-proc; Binary restenosis, MLD, Clin. driven TLR 8 mos post-proc; Clinic. driven TVR 8 mos post-proc; Overall TVR/TLR 8 mos post-proc; Stent thrombosis
Time Frame: 8, 9, 12, 24 mos post-proc
8, 9, 12, 24 mos post-proc

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Conor Medsystems

Investigators

  • Principal Investigator: Joachim Schofer, Universitäres Herz-und Gefäßzentrum Hamburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

February 23, 2007

First Submitted That Met QC Criteria

February 26, 2007

First Posted (Estimate)

February 27, 2007

Study Record Updates

Last Update Posted (Estimate)

October 30, 2009

Last Update Submitted That Met QC Criteria

October 29, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The DECIDE Trial: CP-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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