EVOLVE Short DAPT
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.
NCT02605447
Heart & Vascular,
Heart & Vascular - Interventional Cardiology Trials
R. Jeffrey Westcott, MD
Inclusion Criteria:
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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,
- 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
Exclusion Criteria:
- Subject who is taking (or is planning to take) chronic or lifelong anticoagulation within 15 months following index procedure.
- 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)
Jeremy Gillis
206-215-6573
206-215-1500