Status:
UNKNOWN
Xience Versus Synergy in Left Main PCI
Lead Sponsor:
NHS National Waiting Times Centre Board
Collaborating Sponsors:
Boston Scientific Corporation
Venn Life Sciences
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 c...
Detailed Description
PCI of the left main coronary artery is a complex procedure with increased risk of both short and long-term major cardiac adverse events. With the use of coronary artery stents the outcome has signifi...
Eligibility Criteria
Inclusion
- 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:
- Patient has an indication for coronary artery revascularisation of the left main artery in accordance with the ESC guidelines
- Patient has been discussed with the cardiac surgeon prior to PCI procedure
- Patient is accepted for PCI
- Patient is at least 18 years of age.
- The patient understands and accepts the meaning and the aims of the study and is willing to provide written informed consent
- The patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.
Exclusion
- Not able to receive anti-platelet treatment due to contraindications
- Known allergy to acetylsalicylic acid, clopidogrel, prasugrel or ticagrelor
- Cardiogenic shock
- STEMI within the last 5 days
- Planned surgery within 12 months after stent introduction
- History of bleeding diathesis or active major bleedings
- Major surgery within previous 15 days
- Current participation in another trial which has not yet reached its primary endpoint
- Life expectancy \< 12 months
- Hypersensitivity or contraindication to everolimus or structurally-related compounds, cobalt, chromium, nickel, tungsten, acrylic, platinum and fluoropolymers
- Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
818 Patients enrolled
Trial Details
Trial ID
NCT02303717
Start Date
December 1 2014
End Date
December 1 2020
Last Update
December 1 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.