Registry Experience at the Washington Hospital Center With Drug Eluting Stents - Synergy

Incidence of Major Adverse Cardiac Events Clinical Trial

Official title:

Registry Experience at the Washington Hospital Center With Drug Eluting Stents - Synergy (REWARDS-Synergy)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02823730
• Other study ID #: REWARDS-Synergy
• Status: Completed
• Start date: July 2016
• Est. completion date: May 2023

Study information

• Verified date: May 2023
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To compare the incidence of major adverse cardiac events among a series of patients receiving the Synergy drug-eluting stent with bioabsorbable polymer to historical controls who have received the Promus Premier drug-eluting stent with durable polymer.

Description:

The primary objective of this observational, real-world single-center registry is to compare the incidence of major adverse cardiac events among a series of patients receiving the Synergy drug-eluting stent with bioabsorbable polymer to historical controls who have received the Promus Premier drug-eluting stent with durable polymer. The investigators hypothesize that the long-term incidence (each year following implantation, up to 4 years) of major adverse cardiovascular events, after propensity matching for stent type, will be similar between Synergy and Xience V.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject >18 years of age

2. Underwent PCI with Synergy (alone) DES

Exclusion Criteria:

1. Underwent PCI with a non-Synergy DES (or scaffold) during the same index procedure

2. Patients not taking, or unable to take, dual antiplatelet therapy (DAPT) at the time of screening for the study (patients that discontinue DAPT after enrollment will be included)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Incidence of Major Adverse Cardiac Events

Intervention

Other:
• PCI with Synergy Stent
500 patients who have received the Synergy stent. Data will be mined from the DES registry database for the identified Synergy patients at the following time points, in-hospital and then at 1 year, 2 years, 3 years, and 4 years after percutaneous coronary intervention (PCI).

Locations

Country	Name	City	State
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events (MACE)	major adverse cardiac events (MACE), defined as the composite of: 1. All-cause death; 2. Q-wave myocardial infarction (QwMI): appearance of new pathologic Q waves in the coronary distribution of the target vessel with an increase of creatine kinase-MB to =2 times the reference values (if available); 3. Target vessel revascularization (TVR): need for repeat PCI within the target vessel.	4 years
Secondary	Target lesion revascularization	Need for repeat PCI within the target lesion	4 years
Secondary	Periprocedural creatine kinase-MB	peak level of in-hospital CK-MB post-PCI	4 years
Secondary	Cardiac death	Any death due to a cardiovascular cause	4 years
Secondary	Stent thrombosis	Probable or definite stent thrombosis occurring in the target vessel.	4 years