Improved drug eluting stent for percutaneous coronary intervention of the left main artery in a real world all-comers populatio

Completed

Conditions: 10003184
10003216
10011082
Narrowing left main artery

Registration Number: NL-OMON47380

Lead Sponsor: Golden Jubilee National Hospital, National Times Waiting Board

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 55

Inclusion Criteria

1. Patient has an indication for coronary artery revascularisation of the left main artery in accordance with the ESC guidelines
2. Patient has been discussed with the cardiac surgeon prior to PCI procedure
3. Patient is accepted for PCI
4. Patient is at least 18 years of age.
5. The patient understands and accepts the meaning and the aims of the study and is willing to provide written informed consent
6. The patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.

Exclusion Criteria

1. Not able to receive anti-platelet treatment due to contraindications
2. Known allergy to acetylsalicylic acid, clopidogrel, prasugrel or ticagrelor
3. Cardiogenic shock
4. STEMI within the last 5 days
5. Planned surgery within 12 months after stent introduction
6. History of bleeding diathesis or active major bleedings
7. Major surgery within previous 15 days
8. Current participation in another trial which has not yet reached its primary endpoint
9. Life expectancy < 12 months
10. Hypersensitivity or contraindication to everolimus or structurally-related compounds, cobalt, chromium, nickel, tungsten, acrylic, platinum and fluoropolymers
11. Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is MACE rate, including death from any cause, MI, or<br /><br>ischemia-driven target vessel revascularization (TVR) at 2 years after the<br /><br>procedure.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• The individual events of the primary endpoint<br /><br>• Procedure success (attainment of <30% residual stenosis of the target lesion<br /><br>and no in-hospital DoCE).<br /><br>• Device-oriented Composite Endpoints at 1 month and 6 months and annually to 3<br /><br>years and its individual components. Device-oriented Composite Endpoint (DoCE)<br /><br>is defined as cardiac death, MI not clearly attributable to a non- intervention<br /><br>vessel, and clinically-indicated target lesion revascularization.<br /><br>• Stent thrombosis according to ARC definition at all time points.<br /><br>• The composite of BARC 3 or 5 bleeding at 24 months according to BARC<br /><br>definition<br /><br>• The individual bleeding events (BARC 1, 2, 3, 4 and 5) according to the BARC<br /><br>definition </p><br>