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CoStar™ Paclitaxel-Eluting Coronary Stent Catheter System Evaluation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00422435
First Posted: January 17, 2007
Last Update Posted: October 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Conor Medsystems
  Purpose
This study is designed to evaluate the performance and safety of a new catheter system.

Condition Intervention Phase
Coronary Disease Device: CoStar™ Paclitaxel-Eluting Coronary Stent with SRX catheter Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The PreCiSE Trial: CoStar™ Paclitaxel-Eluting Coronary Stent Catheter System Evaluation

Resource links provided by NLM:


Further study details as provided by Conor Medsystems:

Primary Outcome Measures:
  • Device Success [ Time Frame: At procedure or hospital discharge ]

Secondary Outcome Measures:
  • Lesion success [ Time Frame: 30 days, 6 months and 12 months ]
  • Procedure success [ Time Frame: 30 days, 6 months and 12 months ]
  • Acute Device Performance [ Time Frame: Index procedure ]
  • In hospital, 30-day, 6-month, 12-month MACE [ Time Frame: 30-day, 6-month, 12-month ]

Enrollment: 107
Study Start Date: January 2007
Study Completion Date: May 2008
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug eluting stent
CoStar™ Paclitaxel-Eluting Coronary Stent with SRX catheter
Device: CoStar™ Paclitaxel-Eluting Coronary Stent with SRX catheter
Paclitaxel-Eluting Coronary Stent

Detailed Description:
This study is designed to evaluate acute Device Success, defined as attainment of <50% residual stenosis of the target lesion.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient ≥18 years of age
  • Eligible for percutaneous coronary intervention
  • Documented stable or unstable angina pectoris (Canadian Cardiovascular Society Classification 1, 2, 3, or 4), documented ischemia, or documented silent ischemia
  • Left ventricular ejection fraction ≥25% documented within the last 6 wks
  • Acceptable candidate for coronary artery bypass graft surgery
  • A single de novo lesion per study subject may be treated with the study device
  • Each target lesion may be composed of multiple lesions but must be completely coverable by 1 study stent
  • Cumulative target lesion length per vessel ≤30 mm based on a visual estimate
  • RVD ≥2.5 mm to ≤3.0 mm based on a visual estimate
  • Target lesion diameter stenosis ≥50% and <100% based on a visual estimate
  • Target vessel has not undergone prior revascularization within the preceding 6 months
  • Target lesion must be a minimum 10 mm distance from any previously treated segment of the target vessel

Exclusion Criteria:

  • Known sensitivity to cobalt chromium, paclitaxel or polymeric matrices: Translute or PLGA
  • Planned treatment with any other PCI device in the target vessel(s)
  • MI within 72 hours prior to the index procedure
  • Patient is in cardiogenic shock
  • Cerebrovascular Accident 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 bleeding within the past three months
  • Any prior true anaphylactic reaction to contrast agents
  • Patient is currently, or has been treated with paclitaxel (systemic) within 12 months of the index procedure
  • Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the study
  • Life expectancy of less than 24 months due to other medical conditions
  • Co-morbid 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
  • Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
  • Left main coronary artery disease (stenosis >50%), whether protected or unprotected
  • Target lesion is ostial in location (within 3.0 mm of vessel origin)
  • Target lesion and/or target vessel proximal to the target lesion is severely calcified by visual estimation
  • 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)
  • Angiographic presence of probable or definite thrombus
  • Target vessel will be pre-treated with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon or transluminal extraction catheter immediately prior to stent placement
  • Prior coronary intervention using brachytherapy to any segment of the target vessel
  • 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 percutaneous coronary intervention
  • 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)
  • Prior surgical revascularization of the target vessel with patent graft (saphenous vein graft or arterial conduit)
  • Target lesion lies within 10 mm of prior surgical anastomosis site
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422435


Locations
Belgium
UH Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
Conor Medsystems
Investigators
Principal Investigator: Christophe Dubois, M.D. UH Gasthuisberg
  More Information

Responsible Party: Christophe Dubois, M.D. Principal Investigator, UH Gasthuisberg
ClinicalTrials.gov Identifier: NCT00422435     History of Changes
Other Study ID Numbers: The PreCiSE Trial: CP-03
First Submitted: January 15, 2007
First Posted: January 17, 2007
Last Update Posted: October 24, 2008
Last Verified: October 2008

Keywords provided by Conor Medsystems:
Percutaneous coronary intervention (PCI)
Drug eluting stent (DES)

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action