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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00192881

Enrollment

Unknown

Registered

2005-09-19

Start date

2002-10-31

Completion date

Unknown

Last updated

2010-08-18

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

Conditions

Coronary Artery Disease

Keywords

Percutaneous coronary intervention, Balloon angioplasty, Restenosis, 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

DEVICEBx Sonic & Cypher stent from Cordis

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 * 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

Countries

Denmark

Contacts

Primary ContactHenning Kelbaek, MD

henning.kelbaek@rh.hosp.dk

Backup ContactLene Kloevgaard, RN

lene.kloevgaard@rh.hosp.dk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026