| Eligibility |
Inclusion Criteria:
- 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 bleeding
associated with >1 months of DAPT outweighs the benefit,
- need for chronic or lifelong anticoagulation therapy
- 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 =20,000/µLto =100,000/µL
- In the opinion of investigator, patient is at significant risk of falling
- Patient abuses drugs or alcohol
- Hemoglobin =11.0 u/dl 2. Subject must be 18 years of age 3. Subject must be able to
take study required dual antiplatelet therapy (1 month of P2Y12 inhibitor and aspirin,
13 months of antiplatelet monotherapy) 4. Subject is willing to comply with all
protocol requirements, including agreement to stop taking P2Y12 inhibitor at the
1-month milestone if eligible per protocol 5. Subject (or legal guardian) understands
the trial requirements and the treatment procedures and provides written informed
consent before any trial-specific procedures are performed
Angiographic Inclusion Criteria:
1. Subject must have had implantation of at least one Synergy Stent and the use of Boston
Scientific IVUS for guided stent implantation
2. All implanted stents must be post dilated and must meet the following IVUS success
criteria:
- treated lesions in which the stent cross sectional area exceeds the distal
reference cross sectional area
- if the stent cross sectional area is less than the distal reference cross
sectional area additional post-dilatation must be performed, followed by IVUS
- above IVUS criteria must be met after the 2nd post dilatation NOTE: if the IVUS
criteria is not met after the 2 post dilatation the patient is excluded
3. Stent procedure performed by an approved investigator
4. Vessel diameter = 2.25 mm and =4.0 mm and lesion length =34mm
5. Pre-dilatation is up to the discretion of the investigator
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 Stent during
the index procedure
4. Subject with a planned staged procedure >7 days following the index procedure. (Note:
Planned staged procedures are allowed if performed within 7 days of the index
procedure and only when SYNERGY stents are used for both the index and staged
procedure). Discontinuation of DAPT should occur 1 month after the last PCI procedure
is completed.
5. A staged procedure cannot in a 3rd epicardial vessel if 2 epicardial vessels were
treated during the index procedure
6. 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)
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 12 months following the index procedure (Note: registry, observational, data
collection studies are not exclusionary)
11. Subject is judged inappropriate for discontinuation from P2Y12 inhibitor use at 1
month, due to another condition requiring chronic P2Y12 inhibitor use
- if at the 30 day visit, the patient has had a peri-procedural NSTEMI with an
enzyme elevation >5% of the upper 99th percentile of either CK-MB or Troponin,
the patient should not be taken off DAPT
12. Subject with planned surgery or procedure necessitating discontinuation of P2Y12
inhibitor within 1 month 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 12 months
15. Subject with implantation of a drug-eluting stent other than SYNERGY Stent within 11
months prior to index procedure
16. Have been previously consented for this trial and screen failed
17. Any other clinically significant comorbidities, which in the judgement of the
investigator, could compromise compliance with the protocol, interfere with
interpretation of the study results, or predispose the patient to safety risks.
Angiographic Exclusion Criteria:
1. Target lesion(s) is located within a saphenous vein graft or an arterial graft
2. TIMI flow 0 (total occlusion)
3. Target lesion(s) is located in the left main
4. Potential Target lesion(s) that involve a complex bifurcation (i.e. bifurcation lesion
requiring treatment with more than one stent)
5. Thrombus, or possible thrombus, present in the target vessel (by visual estimate)
6. Patients requiring a treatment of more than two native epicardial vessels
7. More than three lesions in two epicardial vessels unless they can be covered in one
stent
8. In-stent restenosis of target lesion
9. Treatment of non-target lesions or lesions not treated with a Synergy stent
10. Subject who did not receive Boston Scientific IVUS guided stent implantation and
assessment
11. Any target lesion that has not been post dilated and has not had post dilatation IVUS
12. Patients who do not meet the following IVUS success criteria:
- target lesion(s) in which the stent cross sectional area is less than the distal
reference cross sectional area and additional post-dilatation should be
performed, followed by repeat IVUS.
NOTE: if the IVUS criteria is not met after the 2nd post dilatation, the patient is
excluded
|
