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

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Device: CoStar Paclitaxel-eluting coronary stent system	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by Conor Medsystems:

Primary Outcome Measures:

Adjudicated MACE at 30 days [ Time Frame: 30 days ]

Secondary Outcome Measures:

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 ]


Enrollment:	18
Study Start Date:	February 2007
Study Completion Date:	July 2009
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440674

Locations


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

Sponsors and Collaborators

Conor Medsystems

Investigators


Principal Investigator:	Joachim Schofer	Universitäres Herz-und Gefäßzentrum Hamburg

More Information


Responsible Party:	Joachim Schofer, Principal Investigator, Universitäres Herz-und Gefäßzentrum Hamburg
ClinicalTrials.gov Identifier:	NCT00440674 History of Changes
Other Study ID Numbers:	The DECIDE Trial: CP-05
Study First Received:	February 23, 2007
Last Updated:	October 29, 2009

Keywords provided by Conor Medsystems:


Direct Stenting Angioplasty Pre-dilatation Drug-eluting stent

Additional relevant MeSH terms:


Coronary Artery Disease Myocardial Ischemia Coronary Disease Dilatation, Pathologic Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases	Pathological Conditions, Anatomical Paclitaxel Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017

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