A Clinical Trial to Assess the SYNERGY 48 mm Stent System for the Treatment of Atherosclerotic Lesion(s) (EVOLVE48)

• ClinicalTrials.gov Identifier: NCT03350542
• Recruitment Status: Completed
• First Posted: November 22, 2017
• Results First Posted: February 5, 2021
• Last Update Posted: May 14, 2021
• Sponsor: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Device: SYNERGY 48 mm	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective, open label, single arm, multi-center
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: EVOLVE 48: A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of the SYNERGY 48 mm Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)
• Actual Study Start Date: April 12, 2018
• Actual Primary Completion Date: January 16, 2020
• Actual Study Completion Date: January 8, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: SYNERGY 48 mm; 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; A drug eluting coronary stent system

Outcome Measures

Primary Outcome Measures :

1. Target Lesion Failure Rate at 12-months [ Time Frame: 12-month ]
   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.

Secondary Outcome Measures :

1. Target Lesion Revascularization (TLR) Rate at 12 Months [ Time Frame: 12 months ]
   The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) and TLR Coronary Artery Bypass Graft (CABG)
2. Target Vessel Revascularization (TVR) Rate at 12 Months. [ Time Frame: 12 months ]
   TVR overall includes: TVR PCI and TVR CABG
3. Target Vessel Failure (TVF) Rate at 12 Months [ Time Frame: 12 months ]
   Target Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death.
4. MI (Q-wave and Non-Q-wave) Rate [ Time Frame: 12 months ]
   The MI rate includes: MIs related to the Target Vessel, MIs with unknown relationship to the Target Vessel and MIs not related to the Target Vessel.
5. Cardiac Death Rate [ Time Frame: 12 months ]
   Cardiac death is defined as death due to any of the following; acute MI, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, CVA through hospital discharge or CVA suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery and any death in which a cardiac cause cannot be excluded.
6. Non-cardiac Death Rate [ Time Frame: 12 months ]
   Non-cardiac death is defined as a death not due to cardiac causes as previously defined.
7. All Death Rate [ Time Frame: 12 months ]
8. Cardiac Death or MI Rate [ Time Frame: 12 months ]
9. All Death or MI Rate [ Time Frame: 12 months ]
10. All Death/MI/TVR Rate [ Time Frame: 12 months ]
11. Stent Thrombosis Rate [ Time Frame: 12 months ]
12. Periprocedural Technical Success Rate [ Time Frame: Day 1 (periprocedural) ]
    Successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% in 2 near-orthogonal projections with Thrombolysis in Myocardial Infarction (TIMI) 3 flow in the target lesion, as visually assessed by the physician.
13. Periprocedural Clinical Procedural Success Rate [ Time Frame: 12 months ]
    Post-procedure lesion diameter stenosis <30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician, without the occurrence of in-hospital cardiac death, MI, or TVR.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Clinical Inclusion Criteria

• 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
  • OR
  • 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
• Subject is willing to comply with all protocol-required follow-up evaluation Angiographic Inclusion Criteria (visual estimate)
• 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.

Clinical Exclusion Criteria

• 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
• Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L)
• Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
• Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
• Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
• Subject has signs or symptoms of active heart failure (i.e., New York Heart Association (NYHA) class IV) at the time of the index procedure
• Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
• Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
• Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure)
• Subject is a woman who is pregnant or nursing Angiographic Exclusion Criteria (visual estimate)
• Subject has more than 1 target lesion, or more than 1 target lesion and 1 non-target lesion, which will be treated during the index procedure Note: Multiple focal stenoses will be considered as a single lesion if they can be completely covered with 1 study stent
• Treatment of lesions in more than 2 major epicardial vessels Note: 1 target lesion in the target vessel and 1 non-target lesion in non-target vessel is allowed
• Subject has unprotected left main coronary artery disease (>50% diameter stenosis)
• Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent, cutting balloon atherectomy) within 24 hours prior to the index procedure
• Thrombus, or possible thrombus, present in the target vessel (by visual estimate)
• Target lesion meets any of the following criteria:
• Treatment of a single lesion with more than 1 stent
• Left main location
• Lesion 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
• Lesion is located within a saphenous vein graft or an arterial graft
• Lesion will be accessed via a saphenous vein graft or arterial graft
• Lesion with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
• Lesion treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
• Lesion is restenotic from a previous stent implantation or study stent would overlap with a previous stent
• Non-target lesion meets any of the following criteria:
• Located within the target vessel
• Left main location
• Lesion is located within a saphenous vein graft or an arterial graft
• Lesion with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
• Lesion treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
• Requires additional unplanned stents (treatment of the non-target lesion with more than one stent is permitted as long as the stents are initially planned)
• Treatment not 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.

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

United States, Minnesota

HealthEast St. Joseph's Hospital

Saint Paul, Minnesota, United States, 55102

United States, New York

New York Presbyterian Hospital - Columbia University Medical Center

New York, New York, United States, 10032

United States, North Carolina

Rex Hospital

Raleigh, North Carolina, United States, 27607

United States, Ohio

Lindner Center for Research and Education at Christ Hospital

Cincinnati, Ohio, United States, 45219

United States, Pennsylvania

York Hospital

York, Pennsylvania, United States, 17403

United States, Texas

Baylor Heart & Vascular Hospital

Dallas, Texas, United States, 75226

The Heart Hospital Baylor Plano

Plano, Texas, United States, 75024

Latvia

P. Stradins University Hospital

Riga, Latvia

New Zealand

Auckland City Hospital

Auckland, New Zealand, 2025

North Shore Hospital

Takapuna, New Zealand, 0622

United Kingdom

Royal Victoria Hospital

Belfast, United Kingdom, BT12 6BA

Golden Jubilee National Hospital

Glasgow, United Kingdom, G81 4DY

Freeman Hospital

Newcastle Upon Tyne, United Kingdom, NE7 7DN

John Radcliffe Hospital

Oxford, United Kingdom, OX3 9DU

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

• Principal Investigator: Dimitrios Karmpaliotis, MD; New York Presbyterian Hospital

  Study Documents (Full-Text)

Documents provided by Boston Scientific Corporation:

Study Protocol and Statistical Analysis Plan  [PDF] October 16, 2017

More Information

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT03350542
• Other Study ID Numbers: S2356
• First Posted: November 22, 2017
• Results First Posted: February 5, 2021
• Last Update Posted: May 14, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Boston Scientific Corporation:

Drug-Eluting Stents

Additional relevant MeSH terms:

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