CoStar™ Paclitaxel-Eluting Coronary Stent Catheter System Evaluation

Coronary Disease Clinical Trial

Official title:

The PreCiSE Trial: CoStar™ Paclitaxel-Eluting Coronary Stent Catheter System Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422435
• Other study ID #: The PreCiSE Trial: CP-03
• Status: Completed
• Phase: Phase 3
• First received: January 15, 2007
• Last updated: October 23, 2008
• Start date: January 2007
• Est. completion date: May 2008

Study information

• Verified date: October 2008
• Source: Conor Medsystems
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the performance and safety of a new catheter system.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: May 2008
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Device:
• CoStar™ Paclitaxel-Eluting Coronary Stent with SRX catheter
Paclitaxel-Eluting Coronary Stent

Locations

Country	Name	City	State
Belgium	UH Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Conor Medsystems

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Success		At procedure or hospital discharge	No
Secondary	Lesion success		30 days, 6 months and 12 months	No
Secondary	Procedure success		30 days, 6 months and 12 months	No
Secondary	Acute Device Performance		Index procedure	No
Secondary	In hospital, 30-day, 6-month, 12-month MACE		30-day, 6-month, 12-month	Yes