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Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)

Primary Purpose

Ischaemic Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Coronary Drug Eluting Stents for PCI
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischaemic Heart Disease focused on measuring Coronary complex lesions, Restenosis, Drug eluting stents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Rigshospitalet

Outcomes

Primary Outcome Measures

Minimal lumen diameter
Frequency of restenosis (>50%) at 6 months.

Secondary Outcome Measures

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

Full Information

First Posted
September 8, 2005
Last Updated
September 12, 2005
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00151658
Brief Title
Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)
Official Title
Randomized Multicenter Comparison of Sirolimus Versus Bare Metal Stent Implantation in Complex Coronary Lesions. Acronym: Scand Stent
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischaemic Heart Disease
Keywords
Coronary complex lesions, Restenosis, Drug eluting stents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
322 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Coronary Drug Eluting Stents for PCI
Primary Outcome Measure Information:
Title
Minimal lumen diameter
Title
Frequency of restenosis (>50%) at 6 months.
Secondary Outcome Measure Information:
Title
Diameter stenosis, late loss and loss index at 6 months MACE: death, myocardial infarction, target lesion revascularisation within 12 months and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henning Kelbaek, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
18498953
Citation
Kelbaek H, Klovgaard L, Helqvist S, Lassen JF, Krusell LR, Engstrom T, Botker HE, Jorgensen E, Saunamaki K, Aljabbari S, Thayssen P, Galloe A, Jensen GV, Thuesen L. Long-term outcome in patients treated with sirolimus-eluting stents in complex coronary artery lesions: 3-year results of the SCANDSTENT (Stenting Coronary Arteries in Non-Stress/Benestent Disease) trial. J Am Coll Cardiol. 2008 May 27;51(21):2011-6. doi: 10.1016/j.jacc.2008.01.056.
Results Reference
derived

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Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)

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