SYNergy Stent® System Implantation With Mandatory Intra-VascularUltra-Sound Guidance and Dual Anti-Platelet Therapy

NCT03606642 | Terminated Phase 2 Results DMC FDA Device

• 1 other identifier: SYNIVUS-DAPT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to see if one month of dual antiplatelet therapy (DAPT) combined with the placement of the Synergy® Stent with IVUS (intravascular ultrasound) is safe for patients who are at high risk of bleeding (HBR).

Conditions

Coronary Artery Disease; Atherosclerosis; Stent Placement

Keywords

Cardiovascular disease; peripheral vascular disease (PVD); Ischemia

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Cardiac Death

  Rate of cardiac death from 1 to 13 months post-index procedure in the "as treated" (eligible for 30 day DAPT cessation) population.

  1 to 13 months

• Rate of Myocardial Infarction

  Rate of myocardial infarction (SCAI definition) from 1 to 13 months post-index procedure in the overall enrolled "intent-to-treat" patient population

  1 to 13 months

Secondary Outcomes (6)

• Number of Participants With Definite/Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition

  1 to 13 months

• Number of Participants With Major Bleeding

  1 to 13 months

• Number of Participants With Ischemia-driven (ID) Target Vessel Revascularization,

  1 to 13 months

• Number of Participants With Target Vessel Failure

  1 to 13 months

• Number of Participants With All-Cause Death

  1 to 13 months

Study Arms (1)

PCI with 30 day DAPT Therapy

EXPERIMENTAL

Single group of patients undergoing IVUS stent placement for PCI with 30 day DAPT therapy regimen. DAPT therapy consists of Aspirin (325 mg loading dose \[if applicable\] and 81 mg for maintenance dose) and P2Y12 Inhibitor (INFO ABOUT THE DRUGS)

Drug: Dual Antiplatelet (DAPT) Therapy; Device: The Synergy® stent

Interventions

Dual Antiplatelet (DAPT) Therapy DRUG

DAPT - one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient) with Aspirin. Aspirin loading dose (LD) = 325 mg. Aspirin maintenance dose (MD) = 81 mg. P2Y12 Inhibitor Loading Dose (investigator preference): Clopidogrel 600 mg PO x 1 or 75 mg PO daily x 4; Prasugrel 60 mg PO x 1; Ticagrelor 180 mg PO x 1. P2Y12 Inhibitor Maintenance Dose (investigator preference): Clopidogrel 75 mg PO daily; Prasugrel 10 mg PO daily; Ticagrelor 90 mg PO BID.

Also known as: Ticagrelor (Brilinta), Clopidogrel (Plavix), Prasugrel (Effient) with Aspirin

PCI with 30 day DAPT Therapy

The Synergy® stent DEVICE

IVUS guided stent

PCI with 30 day DAPT Therapy

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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:
• Greater than or equal to 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 (microliters)
• 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
• Subject must have had implantation of at least one Synergy Stent and the use of Boston Scientific IVUS for guided stent implantation
• 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

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 Stent during the index procedure
• 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.
• A staged procedure cannot in a 3rd epicardial vessel if 2 epicardial vessels were treated during the index procedure
• 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 previously treated at any time with intravascular brachytherapy
• Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
• 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 creatine kinase-myocardial band (CK-MB) or Troponin, the patient should not be taken off DAPT
• Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 1 month 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 12 months
• Subject with implantation of a drug-eluting stent other than SYNERGY Stent within 11 months prior to index procedure
• Have been previously consented for this trial and screen failed

Sponsors & Collaborators

• HonorHealth Research Institute: lead
• Boston Scientific Corporation: collaborator

Study Sites (3)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

Massachusetts General Hospital, Corrigan Minehan Heart Center

Boston, Massachusetts, 02114, United States

Location

Northwell Hospital Systems

New York, New York, 10075, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis; Cardiovascular Diseases; Peripheral Vascular Diseases; Ischemia

Interventions

2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine; Therapeutics; Ticagrelor; Clopidogrel; Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Piperazines

Results Point of Contact

• Title: Joanne Saczynski, MSN, RN, ACRP-CP
• Organization: HonorHealth Research Institute

jsaczynski@honorhealth.com

480-323-1046

Study Officials

• David Rizik, MD

  HonorHealth Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: DAPT or Dual Antiplatelet Therapy is a combination of two medications given after a percutaneous coronary intervention (PCI) with a drug eluting stent. The medications used for DAPT are low dose Aspirin (81mg) and one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient). Because the patients are considered to be at a high risk for bleeding due to one or a combination of reasons this study is trying to determine if a shorter use of DAPT in combination with the Synergy® stent and an imaging tool called IVUS used during your PCI procedure is safe and effective to reduce the potential for serious bleeding events and early stent thrombosis. The Synergy® stent was chosen because of its enhanced method of healing and reduced inflammation of the artery after placement. The Synergy stent may be a better choice for patients who are at high risk for bleeding and could benefit from a shortened period of DAPT.

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: July 31, 2018
• Study Start: November 19, 2018
• Primary Completion: December 31, 2021
• Study Completion: August 8, 2022
• Last Updated: December 27, 2024
• Results First Posted: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)