Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00151658

Enrollment

322

Registered

2005-09-09

Start date

2002-10-31

Completion date

2006-06-30

Last updated

2005-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischaemic Heart Disease

Keywords

Coronary complex lesions, Restenosis, Drug eluting stents

Brief 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.

Interventions

DEVICECoronary Drug Eluting Stents for PCI

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Minimal lumen diameter	—
Frequency of restenosis (>50%) at 6 months.	—

Secondary

Measure	Time frame
Diameter stenosis, late loss and loss index at 6 months MACE: death, myocardial infarction, target lesion revascularisation within 12 months and 24 months	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026