NCT02499692

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started May 2015

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
4 months until next milestone

Results Posted

Study results publicly available

January 18, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 16, 2020

Status Verified

August 1, 2020

Enrollment Period

5 months

First QC Date

April 30, 2015

Results QC Date

December 11, 2015

Last Update Submit

August 31, 2020

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Target Lesion Revascularization (TLR) Rate

    30 days

  • Target Lesion Failure (TLF) Rate

    30 days

  • Target Vessel Revascularization (TVR) Rate

    30 days

  • Target Vessel Failure (TVF) Rate

    30 days

  • Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate

    30 days

Study Arms (1)

SYNERGYTM Coronary Stent System

EXPERIMENTAL

Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System

Device: SYNERGYTM Coronary Stent System

Interventions

SYNERGYTM Coronary Stent SystemDEVICE

SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System

SYNERGYTM Coronary Stent System

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

AeroSpace center hospital

Beijing, China

Location

the second hospital of Jilin Unversity

Changcun, China

Location

Daqing General Oil Field Hospital

Daqing, China

Location

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, China

Location

The First Hospital of Lanzhou University

Lanzhou, China

Location

General Hospital of SY Military Institute

Shenyang, China

Location

TEDA International Cardiovascular Hospital

Tianjin, China

Location

Wuhan Asia Heart Hospital

Wuhan, China

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

Title
Dr Hanyaling
Organization
The General Hospital of ShenYang Military
hanyl@medmail.com.cn
02428851876

Study Officials

  • Yalin Han

    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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2015

First Posted

July 16, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2015

Study Completion

August 1, 2017

Last Updated

September 16, 2020

Results First Posted

January 18, 2016

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(8)