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Coronary Artery DiseaseEVOLVE-CHINANCT01966159

The EVOLVE China Clinical Trial

A study testing SYNERGY Investigational Device and PE Plus Investigational Device in people with Coronary Artery Disease, run by Boston Scientific Corporation at 14 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
SYNERGY Investigational Device and PE Plus Investigational Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
412 participants
Where
14 sitesChina
Study dates
Oct 2013to Dec 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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])
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  • 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
  • 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
  • CE9. Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, Coumadin) for indications other than acute coronary syndrome
  • CE10. Subject with out of range complete blood count (CBC) values that are determined by the study physician to be clinically significant.
  • CE11. Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
  • CE12. Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L)
  • CE13. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • CE14. Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
  • CE15. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
  • CE16. Subject has signs or symptoms of active heart failure (i.e., NYHA class IV) at the time of the index procedure
  • CE17. Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
  • CE18. Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
  • CE19. 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)
  • CE20. Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)
  • CE21. Target vessel has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to the index procedure
  • AE1. Planned treatment of more than 2 lesions
  • AE2. Planned treatment of lesions in more than 2 major epicardial vessels
  • AE3. Planned treatment of a single lesion with more than 1 stent Note: Planned use of 2 overlapping stents will be allowed in subjects randomized to PROMUS Element Plus where lesion length is ≥28 mm and 2.25 mm stents are used.
  • AE4. Target lesion meets any of the following criteria:
  • Left main location
  • Located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate
  • Located within a saphenous vein graft or an arterial graft
  • Will be accessed via a saphenous vein graft or an arterial graft
  • TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
  • Thrombus, or possible thrombus, present in the target vessel
  • Excessive tortuosity proximal to or within the lesion
  • Excessive angulation proximal to or within the lesion
  • Target lesion and/or the target vessel proximal to the target lesion is moderately to severely calcified by visual estimate
  • Involves a side branch ≥2.0 mm in diameter by visual estimate or a side branch <2.0 mm in diameter by visual estimate which requires treatment
  • AE5. Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
  • AE6. Target lesion(s) is restenostic from a previous stent implantation or study stent would overlap with a previous stent
  • AE7. Subject has unprotected left main coronary artery disease (>50% diameter stenosis)
  • AE8. Subject has protected left main coronary artery disease (>50% diameter stenosis in the LMCA with bypass graft(s) to the left coronary artery) and a target lesion in the LAD or LCX

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

China14 sites

  • Beijing Affiliated Hospital of Armed Police Medical College

    Beijing

  • Beijing Hospital of the Ministry of Health

    Beijing

  • Cardiovascular Institute and Fu Wai Hospital

    Beijing

  • Peking University First Hospital

    Beijing

  • Daqing General Oil Field Hospital

    Daqing

  • Guangdong Cardiovascular Institute of Guangdong Provincial Hospital

    Guangzhou

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

    Hangzhou

  • Shengjing Hospital of China Medical University

    Shengyang

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

    Shenyang, 110015

  • TEDA International Cardiovascular Hospital

    Tianjin

  • Logistics University of PAPF Affiliated Hospital

    Tianjing

  • Wuhan Asia Heart Hospital

    Wuhan

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

    Xi'an

  • Xijing Hospital, Fourth Military Medical University

    Xi'an

Other trials in China

About this study

Official title: EVOLVE China: A Prospective, Multicenter Trial to Assess the Safety and Effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) for the Treatment of Atherosclerotic Lesion(s)

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)

Read the detailed description

The EVOLVE China clinical trial is designed to assess the safety and effectiveness of the SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) in native coronary arteries in China. The SYNERGY™ Stent System (Boston Scientific Corporation [BSC Corporation], Natick, Massachusetts, United States) is based on the well characterized Element™ stent platform and utilizes a bioabsorbable poly(DL-lactide-co-glycolide) (PLGA) polymer to deliver everolimus.

While SYNERGY is a new generation DES, the safety and effectiveness of the Element stent platform in combination with everolimus in the form of the PROMUS Element stent has been established in the PLATINUM Clinical Trial Program.The PROMUS Element Plus stent (control device) uses the same stent platform as PROMUS Element stent with a modified balloon component on the Stent Delivery System to improve overall system deliverability. In addition, the previous version of the SYNERGY stent, the SYNERGY First Human Use stent (SYNERGY FHU stent) has been investigated in the EVOLVE FHU trial which has completed its primary endpoint and demonstrated comparable safety and efficacy profile of SYNERGY FHU to PROMUS Element up to 1-year follow-up (28). SYNERGY has been approved by CE Mark.

Being tested
SYNERGY Investigational Device, PE Plus Investigational Device
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SYNERGY Investigational DeviceDevice

    percutaneous coronary intervention

  • PE Plus Investigational DeviceDevice

    percutaneous coronary intervention

Study groups in NCT01966159
Study groupRoleWhat they receive
SYNERGY Investigational DeviceExperimentalSYNERGY Stent System
Receives: Device: SYNERGY Investigational Device
PE Plus Investigational DeviceActive comparatorPE Plus Stent System
Receives: Device: PE Plus Investigational Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The In-stent Late Loss Measured by Quantitative Coronary Angiography

    Measured: at 9 months post-index procedure.

Secondary outcomes (1)

  1. Target Lesion Revascularization (TLR) Rate

    Target lesion revascularization is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.

    Measured: 12 months post-index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionJul 2014
  4. Study completionDec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
412 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01966159
Sponsor's protocol ID
S2279
Acronym
EVOLVE-CHINA
Status last verified
Nov 2023
First submitted
17 Oct 2013
Last updated
15 Nov 2023
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing SYNERGY Investigational Device and PE Plus Investigational Device in people with Coronary Artery Disease, run by Boston Scientific Corporation at 14 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The In-stent Late Loss Measured by Quantitative Coronary Angiography (time frame: at 9 months post-index procedure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01966159.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.

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The EVOLVE China Clinical Trial (NCT01966159) | AzTrials