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OpenTrials
Completed

NCT Number: NCT02823730

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

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.

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Key information

Conditions

Incidence of Major Adverse Cardiac Events

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject >18 years of age
  • Underwent PCI with Synergy (alone) DES

Exclusion criteria

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

Treatment and study plan

PCI with Synergy Stent

Other

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).

Primary outcomes

  1. Major adverse cardiac events (MACE)

    Time frame: 4 years

    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.

Secondary outcomes

  1. Target lesion revascularization

    Time frame: 4 years

    Need for repeat PCI within the target lesion

  2. Periprocedural creatine kinase-MB

    Time frame: 4 years

    peak level of in-hospital CK-MB post-PCI

  3. Cardiac death

    Time frame: 4 years

    Any death due to a cardiovascular cause

  4. Stent thrombosis

    Time frame: 4 years

    Probable or definite stent thrombosis occurring in the target vessel.

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2016
Registry last updated
May 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.