Xience Versus Synergy in Left Main PCI

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A prospective, randomized, multicenter study in patients with an indication for coronary artery revascularisation who have been accepted for percutaneous coronary intervention (PCI) of the left main coronary artery. Patients will undergo standard PCI of the left main coronary artery and will be randomized in a 1:1 fashion to the Synergy stent or to the XIENCE stent. Dual antiplatelet therapy (DAPT) will be stopped at t=4 months in the Synergy arm whereas in the control arm DAPT will be continued for 12 months. A subgroup of 100 patients will have control angiography with Optical Coherence Tomography (OCT) at t=3 months after treatment.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NHS National Waiting Times Centre Board
• Collaborators: Boston Scientific Corporation; Cardialysis B.V.; Diagram B.V.; Venn Life Sciences
• Treatments: Aspirin; Clopidogrel; Prasugrel Hydrochloride; Ticagrelor

Criteria

Inclusion Criteria:

• Patients with an indication for coronary artery revascularisation by ESC guidelines and accepted for PCI of the left main coronary artery will be included in the study.

Main 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