SYNERGY China: Assess SYNERGY Stent in China

Cardiovascular Diseases Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02499692
• Other study ID #: S2342
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: August 2017

Study information

• Verified date: August 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: August 2017
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion Criteria:

1. Subject must be at least 18 -75 years of age

2. Subject is eligible for percutaneous coronary intervention (PCI)

3. 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:

1. Planned PCI (including staged procedures) or CABG after the index procedure

2. Subject with out of range complete blood count (CBC) values that are determined by the study physician to be clinically significant.

3. Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L)

4. 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

5. 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.

6. 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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Device:
• SYNERGYTM Coronary Stent System
SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 day
Secondary	Target Lesion Revascularization (TLR) Rate		30 days
Secondary	Target Lesion Failure (TLF) Rate		30 days
Secondary	Target Vessel Revascularization (TVR) Rate		30 days
Secondary	Target Vessel Failure (TVF) Rate		30 days
Secondary	Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate		30 days