The EVOLVE China Clinical Trial

NCT01966159 | Completed Results

• 1 other identifier: S2279
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study is to assess the safety and effectiveness of the SYNERGY™ Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate)

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• The In-stent Late Loss Measured by Quantitative Coronary Angiography

  at 9 months post-index procedure.

Secondary Outcomes (1)

• Target Lesion Revascularization (TLR) Rate

  12 months post-index procedure

Other Outcomes (1)

• Target Lesion Failure (TLF) Rate

  12 months post-index procedure

Study Arms (2)

SYNERGY Investigational Device

EXPERIMENTAL

SYNERGY Stent System

Device: SYNERGY Investigational Device

PE Plus Investigational Device

ACTIVE COMPARATOR

PE Plus Stent System

Device: PE Plus Investigational Device

Interventions

SYNERGY Investigational Device DEVICE

percutaneous coronary intervention

SYNERGY Investigational Device

PE Plus Investigational Device DEVICE

percutaneous coronary intervention

PE Plus Investigational Device

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CI1. Subject must be 18 -75 years of age
• CI2. 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
• CI3. Subject is eligible for percutaneous coronary intervention (PCI)
• CI4. Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
• CI5. Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
• CI6. Subject is willing to comply with all protocol-required follow-up evaluation
• CI7. Subject has a left ventricular ejection fraction (LVEF) \>30% as measured within 60 days prior to enrollment
• AI1. Target lesion(s) must be de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm
• AI2. Target lesion(s) length must be ≤34 mm (by visual estimate)
• AI3. Target lesion(s) must have visually estimated stenosis ≥50% and \<100% with thrombolysis in Myocardial Infarction (TIMI) flow \>1 and one of the following: stenosis ≥70%, abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test, or elevated biomarkers prior to the procedure
• AI4. Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)
• AI5. The first lesion treated must be successfully predilated/pretreated

You may not qualify if:

• CE1. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI .
• CE2. Subject with unstable angina or recent MI (within 1 week) must have CK/CK-MB or troponin documented prior to the procedure and are excluded if any of the following criteria are met at the time of the index procedure:
• If CK MB \>2× upper limit of normal (ULN), the subject is excluded regardless of the CK Total.
• If CK Total \>2× ULN, either CK-MB or troponin must be drawn and the subject is excluded if either CK-MB or troponin is abnormal.
• If neither CK Total or CK MB is drawn but troponin is, the subject is excluded if troponin \>1× ULN and the subject has at least one of the following:
• Subject has ischemic symptoms and ECG changes indicative of ongoing ischemia (e.g., \>1 mm ST segment elevation or depression in consecutive leads or new left bundle branch block \[LBBB\])
• Development of pathological Q waves in the ECG or
• Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
• CE3. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, or intractable ventricular arrhythmias or ongoing intractable angina
• CE4. Subject has received an organ transplant or is on a waiting list for an organ transplant
• CE5. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
• CE6. Planned PCI or CABG after the index procedure
• CE7. Subject has a known allergy to 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, clopidogrel, or aspirin) and contrast (that cannot be adequately premedicated)
• CE8. Subject has a known condition(s) of the following (as assessed from the time of screening through the day of index procedure):
• Other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 24 months

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (14)

Beijing Affiliated Hospital of Armed Police Medical College

Beijing, China

Location

Beijing Hospital of the Ministry of Health

Beijing, China

Location

Cardiovascular Institute and Fu Wai Hospital

Beijing, China

Location

Peking University First Hospital

Beijing, China

Location

Daqing General Oil Field Hospital

Daqing, China

Location

Guangdong Cardiovascular Institute of Guangdong Provincial Hospital

Guangzhou, China

Location

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, China

Location

Shengjing Hospital of China Medical University

Shengyang, China

Location

Shenyang Northern Hospital (The General Hospital of Shenyang Military Region)

Shenyang, 110015, China

Location

TEDA International Cardiovascular Hospital

Tianjin, China

Location

Logistics University of PAPF Affiliated Hospital

Tianjing, China

Location

Wuhan Asia Heart Hospital

Wuhan, China

Location

First Affiliated Hospital of Medical College of Xi'an Jiaotong University

Xi'an, China

Location

Xijing Hospital, Fourth Military Medical University

Xi'an, China

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: Dr. Hanyaling
• Organization: Shenyang Northern Hospital (The General Hospital of Shenyang Military Region)

hanyl@medmail.com.cn

024-28897310

Study Officials

• Yaling Han, Dr.

  Shenyang Northern Hospital (The General Hospital of Shenyang Military Region)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: October 21, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2020
• Last Updated: November 15, 2023
• Results First Posted: February 18, 2016

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (14)