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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47380
Enrollment
55
Registered
2015-06-22
Start date
2015-07-14
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Narrowing left main artery

Interventions

Patients who are scheduled to undergo standard PCI of the left main coronary artery will be randomized in a 1:1 fashion to the Synergy stent arm or to XIENCE stent arm. Dual antiplatelet therapy (DA

Sponsors

Golden Jubilee National Hospital, National Times Waiting Board
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The primary endpoint is MACE rate, including death from any cause, MI, or ischemia-driven target vessel revascularization (TVR) at 2 years after the procedure.

Secondary

MeasureTime frame
• The individual events of the primary endpoint • Procedure success (attainment of

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)