Cardiovascular DiseasesNCT02499692

SYNERGY China: Assess SYNERGY Stent in China

A study testing SYNERGYTM Coronary Stent System in people with Cardiovascular Diseases, run by Boston Scientific Corporation at 8 sites in China.

Completed

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

Official record

Search all trials

Trial summary

Prospective, multicenter, single-arm study, enroll 100 patients in no more than 10 sites across China, the primary endpoint is Technical success. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Cardiovascular Diseases
What is being tested?: SYNERGYTM Coronary Stent System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 103 participants
Where: 8 sitesChina
Study dates: May 2015to Aug 2017
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

Subject must be at least 18 -75 years of age
Subject is eligible for percutaneous coronary intervention (PCI)
Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm, length must be ≤34* mm (by visual estimate), Target lesion(s) must have visually estimated stenosis ≥50% and <100% with thrombolysis in Myocardial Infarction (TIMI) flow >1

Who cannot join

Planned PCI (including staged procedures) or CABG after the index procedure
Subject with out of range complete blood count (CBC) values that are determined by the study physician to be clinically significant.
Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L)
Planned treatment of more than 3 lesions, Planned treatment of lesions in more than 2 major epicardial vessels, Planned treatment of a single lesion with more than 1 stent
Target lesion(s) 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.
Target vessel develops a dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C following the pre-dilatation/pre-treatment of the first target lesion

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

China8 sites

AeroSpace center hospital
Beijing
the second hospital of Jilin Unversity
Changcun
Daqing General Oil Field Hospital
Daqing
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou
The First Hospital of Lanzhou University
Lanzhou
General Hospital of SY Military Institute
Shenyang
TEDA International Cardiovascular Hospital
Tianjin
Wuhan Asia Heart Hospital
Wuhan

Other trials in China

About this study

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

Prospective, multicenter, single-arm study, enroll 100 patients in no more than 10 sites across China, the primary endpoint is Technical success.

Read the detailed description

The study is To evaluate clinical and peri-procedural angiographic outcomes for the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System in 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: Cardiovascular Diseases
Being tested: SYNERGYTM Coronary Stent System
Medical subject headings: Cardiovascular Diseases

What participants receive

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

SYNERGYTM Coronary Stent SystemDevice
SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System

Study groups in NCT02499692
Study group	Role	What they receive
SYNERGYTM Coronary Stent System	Experimental	Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System Receives: Device: SYNERGYTM Coronary Stent System

What is being measured

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

Technical Success Rate
Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician
Measured: 1 day

Secondary outcomes (5)

Target Lesion Revascularization (TLR) Rate
Measured: 30 days
Target Lesion Failure (TLF) Rate
Measured: 30 days
Target Vessel Revascularization (TVR) Rate
Measured: 30 days
Target Vessel Failure (TVF) Rate
Measured: 30 days
Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate
Measured: 30 days

Timeline

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

May 2015Aug 2017

First posted16 Jul 2015 (estimated)
Study startMay 2015
Primary completionOct 2015
Study completionAug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02499692
Sponsor's protocol ID: S2342
Status last verified: Aug 2020
First submitted: 30 Apr 2015
Last updated: 16 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)

All Cardiovascular Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SYNERGY China: A Prospective, Multicenter Trial to Assess the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)
ClinicalTrials.gov ID: NCT02499692
Acronym / sponsor ID: S2342
Conditions: Cardiovascular Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: May 2015 (actual)
Primary completion: Oct 2015 (actual)
Study completion: Aug 2017 (actual)
First posted: 16 Jul 2015 (estimated)
Results: Posted 18 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Prospective, multicenter, single-arm study, enroll 100 patients in no more than 10 sites across China, the primary endpoint is Technical success.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SYNERGYTM Coronary Stent System	Experimental	Device: SYNERGYTM Coronary Stent SystemDevice:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subject must be at least 18 -75 years of age
Subject is eligible for percutaneous coronary intervention (PCI)
Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm, length must be ≤34* mm (by visual estimate), Target lesion(s) must have visually estimated stenosis ≥50% and <100% with thrombolysis in Myocardial Infarction (TIMI) flow >1

Key exclusion criteria (6 listed)

Planned PCI (including staged procedures) or CABG after the index procedure
Subject with out of range complete blood count (CBC) values that are determined by the study physician to be clinically significant.
Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L)
Planned treatment of more than 3 lesions, Planned treatment of lesions in more than 2 major epicardial vessels, Planned treatment of a single lesion with more than 1 stent
Target lesion(s) 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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SYNERGYTM Coronary Stent SystemSYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System	Device	SYNERGYTM Coronary Stent System

Primary outcome

Technical Success Rate
Time frame: 1 day
Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician

5 secondary outcomes

Target Lesion Revascularization (TLR) Rate
Time frame: 30 days
Target Lesion Failure (TLF) Rate
Time frame: 30 days
Target Vessel Revascularization (TVR) Rate
Time frame: 30 days
Target Vessel Failure (TVF) Rate
Time frame: 30 days
Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate
Time frame: 30 days

Results and safety

Results posted to the registry on 18 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SYNERGYTM Coronary Stent System	103	103

Primary outcome: Technical Success Rate

Time frame: 1 day. Number. Unit: percentage of participants

Measure	SYNERGYTM Coronary Stent System n = 103
Value	98.1

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SYNERGYTM Coronary Stent System	1 of 103 (1%)	7 of 103 (6.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Cardiovascular Diseases

Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yalin Han principal investigator

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

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SYNERGYTM Coronary Stent System in people with Cardiovascular Diseases, run by Boston Scientific Corporation at 8 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 3 inclusion and 6 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 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 Jan 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?

Technical Success Rate (time frame: 1 day). 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 NCT02499692.

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 16 Sep 2020.