A Clinical Trial to Assess the SYNERGY 48 mm Stent System for the Treatment of Atherosclerotic Lesion(s)

NCT03350542 | Completed Phase 3 Results FDA Device

• 1 other identifier: S2356
• Study Type: interventional
• Target: 100
• Locations: 4 countries
• Sites: 15

Brief Summary

EVOLVE 48 is a prospective, open label, single arm, multi-center trial. The purpose of this study is to assess the FDA requirement for safety and effectiveness of the SYNERGY 48 mm Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) \> 34 mm and ≤ 44 mm in length (by visual estimate) in native coronary arteries ≥2.5 mm to ≤4.0 mm in diameter (by visual estimate).

Conditions

Coronary Artery Disease

Keywords

Drug-Eluting Stents

Outcome Measures

Primary Outcomes (1)

• Target Lesion Failure Rate at 12-months

  The primary endpoint is the 12-month Target Lesion Failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.

  12-month

Secondary Outcomes (13)

• Target Lesion Revascularization (TLR) Rate at 12 Months

  12 months

• Target Vessel Revascularization (TVR) Rate at 12 Months.

  12 months

• Target Vessel Failure (TVF) Rate at 12 Months

  12 months

• MI (Q-wave and Non-Q-wave) Rate

  12 months

• Cardiac Death Rate

  12 months

Study Arms (1)

SYNERGY 48 mm

EXPERIMENTAL

SYNERGY 48 mm is a device/ drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating)

Device: SYNERGY 48 mm

Interventions

SYNERGY 48 mm DEVICE

A drug eluting coronary stent system

SYNERGY 48 mm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 18 years of age
• Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed
• Subject is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for coronary artery bypass grafting (CABG)
• Subject has either:
• Symptomatic coronary artery disease with one of the following: stenosis ≥ 70%, abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test, or elevated biomarkers prior to the procedure
• Documented silent ischemia based on one of the following: abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test, or elevated biomarkers prior to the procedure
• Target lesion must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.5 mm and ≤4.0 mm
• Target lesion length must be \>34 mm and ≤44 mm (by visual estimate)
• Target lesion must have visually estimated stenosis ≥50% and \<100% with thrombolysis in Myocardial Infarction (TIMI) flow \>1
• Coronary anatomy is likely to allow delivery of a study device to the target lesion
• The target lesion must be successfully predilated/pretreated. If a non-target lesion is treated, it should be treated first and should be deemed an angiographic success Note: Angiographic success is a mean lesion diameter stenosis \< 50% (\< 30% for stents) in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of prolonged chest pain or ECG changes consistent with MI.
• Note: Successful predilatation/pretreatment refers to dilatation with a balloon catheter of appropriate length and diameter, or pretreatment with directional or rotational coronary atherectomy, laser or cutting/scoring balloon with no greater than 50% residual stenosis and no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C.

You may not qualify if:

• Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)
• Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
• Subject has received an organ transplant or is on a waiting list for an organ transplant
• Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
• Planned PCI (including staged procedures) or CABG after the index procedure
• Subject previously treated at any time with intravascular brachytherapy
• Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g., platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin)
• Subject has one of the following (as assessed prior to enrollment):
• Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months
• Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
• Planned procedure that may cause non-compliance with the protocol or confound data interpretation
• Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin) for indications other than acute coronary syndrome
• Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3
• Subject has a white blood cell (WBC) count \< 3,000 cells/mm3
• Subject has documented or suspected liver disease, including laboratory evidence of hepatitis

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (15)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

HealthEast St. Joseph's Hospital

Saint Paul, Minnesota, 55102, United States

Location

New York Presbyterian Hospital - Columbia University Medical Center

New York, New York, 10032, United States

Location

Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

Lindner Center for Research and Education at Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

York Hospital

York, Pennsylvania, 17403, United States

Location

Baylor Heart & Vascular Hospital

Dallas, Texas, 75226, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75024, United States

Location

P. Stradins University Hospital

Riga, Latvia

Location

Auckland City Hospital

Auckland, 2025, New Zealand

Location

North Shore Hospital

Takapuna, 0622, New Zealand

Location

Royal Victoria Hospital

Belfast, BT12 6BA, United Kingdom

Location

Golden Jubilee National Hospital

Glasgow, G81 4DY, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Patricia O'Mara
• Organization: Boston Scientific

patricia.omara@bsci.com

518-744-0046

Study Officials

• Dimitrios Karmpaliotis, MD

  New York Presbyterian Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, open label, single arm, multi-center

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 22, 2017
• Study Start: April 12, 2018
• Primary Completion: January 16, 2020
• Study Completion: January 8, 2021
• Last Updated: May 14, 2021
• Results First Posted: February 5, 2021

Record last verified: 2021-04

Locations

US (8); NZ (2); LA (1); GB (4)