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Completed

NCT Number: NCT00151658

Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)

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.

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Key information

Conditions

Ischaemic Heart Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, DK-2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary Drug Eluting Stents for PCI

Device

Primary outcomes

  1. Minimal lumen diameter

  2. Frequency of restenosis (>50%) at 6 months.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2006
First posted
Sep 9, 2005
Registry last updated
Sep 14, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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