EVOLVE Short DAPT Study

Completed · Phase 4

Conditions studied: Coronary Artery Disease

In brief

The EVOLVE Short DAPT Study is a prospective, multicenter, single-arm study designed to assess the safety of 3-month DAPT in subjects at high risk for bleeding undergoing PCI with a SYNERGY Stent System.

Key facts

Study ID: NCT02605447
Run by: Boston Scientific Corporation
People needed: 2009
Starts: 2016-02-16
Expected to finish: 2019-07-17
Last updated by the study team: 2020-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject is considered at high risk for bleeding, defined as meeting one or more of the following criteria at the time of enrollment:
≥ 75 years of age and, in the opinion of the investigator, the risk of major bleeding associated with >3 months of DAPT outweighs the benefit,
need for chronic or lifelong anticoagulation,
history of major bleeding (severe/life threatening or moderate bleeding based on the GUSTO classification) within 12 months of the index procedure,
history of stroke (ischemic or hemorrhagic),
renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent),
platelet count ≤100,000/μL
Subject must be at least 18 years of age
Subject must have had implantation of at least one SYNERGY stent within the preceding 3 calendar days
Subject must be able to take study required antiplatelet therapy (as required per protocol)
Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at the 3-month milestone, if eligible per protocol
Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any study-specific procedures are performed
For subjects less than 20 years of age enrolled at a Japanese site, the subject/ the subject's legal representative must provide written informed consent before any study-specific tests or procedures are performed

You may not qualify if…

Subject with an indication for the index procedure of acute ST elevation MI (STEMI)
Subject with an indication for the index procedure of Non ST elevation MI (NSTEMI), based on the 3rd Universal MI definition
Subject with treatment with another coronary stent, other than SYNERGY, during the index procedure
Subject with planned staged procedures. (Note: Planned staged procedures are allowed if performed within 7 days and with only SYNERGY stents).
Subject has a known allergy to contrast (that cannot be adequately pre-medicated), the SYNERGY stent system or protocol-required concomitant medications (e.g., everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors and aspirin)
Subject with implantation of a drug-eluting stent within 9 months prior to index procedure
Subject previously treated at any time with intravascular brachytherapy
Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
Subject is participating in an investigational drug or device clinical trial that has not reached its primary endpoint (Note: registry, observational, data collection studies are not exclusionary)
Subject intends to participate in an investigational drug or device clinical trial within 15 months following the index procedure (Note: registry, observational, data collection studies are not exclusionary)
Subject judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months, due to another condition requiring chronic P2Y12 inhibitor use
Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 3 months following index procedure
Subject is a woman who is pregnant or nursing
Subject with a current medical condition with a life expectancy of less than 15 months
Target lesion(s) is located in the left main
Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate
Subject has unprotected left main coronary artery disease ( > 50% diameter stenosis)
Planned treatment of more than 3 lesion
Planned treatment of lesions in more than 2 major epicardial vessels
Target lesion(s) treated that involve complex bifurcation (i.e. bifurcation lesion requiring treatment with more than one stent)
Target lesion(s) is restenotic from a previous stent implantation
Target lesion(s) is located within a saphenous vein graft or an arterial graft
Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
Thrombus, or possible thrombus, present in the target vessel (by visual estimate)

Where it is running

St. Joseph's Hospital & Medical Center — Phoenix, Arizona, United States
Baptist Health Medical Center (Little Rock) — Little Rock, Arkansas, United States
Arkansas Heart Hospital — Little Rock, Arkansas, United States
Bakersfield Memorial Hospital — Bakersfield, California, United States
USC Medical Center — Los Angeles, California, United States
Cedars - Sinai Medical Center — Los Angeles, California, United States
El Camino Hospital — Mountain View, California, United States
HCA Riverside Community Hospital — Riverside, California, United States
Sutter Medical Center, Sacramento — Sacramento, California, United States
University of California, Davis Medical Center — Sacramento, California, United States
Kaiser Foundation Hospital - San Francisco — San Francisco, California, United States
John Muir Medical Center — Walnut Creek, California, United States
South Denver Cardiology Associates, PC — Littleton, Colorado, United States
Yale-New Haven Hospital — New Haven, Connecticut, United States
Washington Hospital Center — Washington D.C., District of Columbia, United States
JFK Medical Center — Atlantis, Florida, United States
Morton Plant Mease Healthcare System — Clearwater, Florida, United States
North Florida Regional Medical Center — Gainesville, Florida, United States
Memorial Regional Hospital — Hollywood, Florida, United States
Mediquest Research at Munroe Regional Medical Center — Ocala, Florida, United States
Florida Hospital — Orlando, Florida, United States
Florida Hospital Heartland Medical Center — Sebring, Florida, United States
Tallahassee Memorial Hospital — Tallahassee, Florida, United States
University Hospital — Augusta, Georgia, United States
Banner Good Samaritan Regional Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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