Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease

Coronary Artery Disease Clinical Trial

Official title:

Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease. A Randomised Comparison of Optimal Balloon Angioplasty and Primary Implantation of Stents With and Without Drug Elution in Complex Coronary Lesions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00192881
• Other study ID #: SCANDSTENT A
• Status: Not yet recruiting
• Phase: N/A
• First received: September 12, 2005
• Last updated: August 17, 2010
• Start date: October 2002

Study information

• Verified date: July 2010
• Source: Rigshospitalet, Denmark
• Contact: Henning Kelbaek, MD
• Email: henning.kelbaek[@]rh.hosp.dk
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical and angiographic outcome of implantation of stents eluting or not eluting Sirolimus in patients with complex coronary artery lesions suitable for percutaneous coronary intervention.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Stable, or unstable angina and/or objective signs of myocardial ischaemia

• Informed consent

• Optimal result (< 35% residual stenosis and < type C dissection) after balloon angioplasty

• Lesions should be de novo and located in native vessels with a diameter > 2.25 mm.

• Complex lesions to be included should have at least one of the following characteristics:

• ostial in location (< 5 mm from ostium)

• total occlusions with a length = 15 mm

• bifurcational (side branch > 1.75 mm in diameter)

• angulated (> 45° within lesion)

Exclusion criteria:

Patients:

• Other severe disease with an expected survival < 1 year

• Other significant cardiac disease

• Known allergy against paclitaxel, clopidogrel (or ticlopidine),

• Myocardial infarction within 3 days of the index procedure

• Linguistic difficulties needing an interpreter

• Renal insufficiency (p-creatinine > 200 micromol/l)

• Gastrointestinal bleeding within 1 month

• Childbearing potential or pregnancy

• Participation in another study

Lesions:

• Unprotected left main disease

• Restenosis

• Lesions containing visible thrombus

• Treatment with other modality than balloon or stent (ablation, brachytherapy, ultrasound) in connection with the index procedure

• Diffuse coronary disease distal to the treated lesion

• Heavily calcification

• Lesion located in saphenous vein graft

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Bx Sonic & Cypher stent from Cordis

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Cardiac Cath Lab	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark,