Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)

Ischaemic Heart Disease Clinical Trial

Official title:

Randomized Multicenter Comparison of Sirolimus Versus Bare Metal Stent Implantation in Complex Coronary Lesions. Acronym: Scand Stent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151658
• Other study ID #: SCANDSTENT
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: September 12, 2005
• Start date: October 2002
• Est. completion date: June 2006

Study information

• Verified date: September 2005
• Source: Rigshospitalet, Denmark
• Contact: n/a
• 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: Completed
• Enrollment: 322
• Est. completion date: June 2006
• 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 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 stainless steel.

• 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
• Ischaemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• Coronary Drug Eluting Stents for PCI

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimal lumen diameter
Primary	Frequency of restenosis (>50%) at 6 months.
Secondary	Diameter stenosis, late loss and loss index at 6 months MACE: death, myocardial infarction, target lesion revascularisation within 12 months and 24 months