EVOLVE Short DAPT Study

• Status: Completed
• Trial end date: 2019-07-17
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Scientific Corporation
• Treatments: Chromium; Everolimus

Criteria

Inclusion Criteria:

1. 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

2. Subject must be at least 18 years of age

3. Subject must have had implantation of at least one SYNERGY stent within the preceding 3 calendar days

4. Subject must be able to take study required antiplatelet therapy (as required per protocol)

5. 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

6. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any study-specific procedures are performed

7. 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:

1. Subject with an indication for the index procedure of acute ST elevation MI (STEMI)

2. Subject with an indication for the index procedure of Non ST elevation MI (NSTEMI), based on the 3rd Universal MI definition

3. Subject with treatment with another coronary stent, other than SYNERGY, during the index procedure

4. Subject with planned staged procedures. (Note: Planned staged procedures are allowed if performed within 7 days and with only SYNERGY stents).

5. 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)

6. Subject with implantation of a drug-eluting stent within 9 months prior to index procedure

7. Subject previously treated at any time with intravascular brachytherapy

8. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding

9. 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)

10. 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)

11. Subject judged inappropriate for discontinuation from P2Y12 inhibitor use at 3 months, due to another condition requiring chronic P2Y12 inhibitor use

12. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 3 months following index procedure

13. Subject is a woman who is pregnant or nursing

14. Subject with a current medical condition with a life expectancy of less than 15 months

15. Target lesion(s) is located in the left main

16. 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

17. Subject has unprotected left main coronary artery disease ( > 50% diameter stenosis)

18. Planned treatment of more than 3 lesion

19. Planned treatment of lesions in more than 2 major epicardial vessels

20. Target lesion(s) treated that involve complex bifurcation (i.e. bifurcation lesion requiring treatment with more than one stent)

21. Target lesion(s) is restenotic from a previous stent implantation

22. Target lesion(s) is located within a saphenous vein graft or an arterial graft

23. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing

24. Thrombus, or possible thrombus, present in the target vessel (by visual estimate)