A Prospective Multicenter Trial Evaluating Helios Biodegr... | NCT01880879

Studies
A Prospective Multicenter Trial Evaluating Helios Biodegradable Polymer SES Safety and Effectiveness in CAD Treatment

NCT01880879

Sponsor

Kinhely Bio-tech Co., Ltd.

Status

Unknown status

Last Update Posted

Jun 24, 2013Estimated

Enrollment

800Estimated

Phase

Phase 4

Conditions

Coronary Artery Disease

Interventions

helios stent

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jan 2015Estimated

Completion Date

Jan 2015Estimated

First Submitted Date

May 30, 2013

First Submission Date that Met QC Criteria

Jun 16, 2013

First Posted Date

Jun 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2013

Last Update Posted Date

Jun 24, 2013Estimated

Name	Class
RenJi Hospital	OTHER
Peking University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

research topic:helios After registration of clinical research bidders:kinhely bio-tech Co.Ltd study design:A prospective single treatment group multicenter clinical study Number of patients:Included in the subjects of 800 cases Main research purpose:Evaluation of safety and effectiveness Mainly studies the finish:1 year target lesion of the failure

Inclusion criteria :

one:Gender not limited at the age of 18 to 80 two:myocardial ischemia or angina symptoms of coronary artery disease three:A narrow is less than 50% treated with stents four:Comply with the instructions five:Voluntarily signed the informed consent form exclusion criteria: one:Pregnant women two:cardiac shock three:Against a suppository medicines or allergies four:Participated in other test research in the first 6 months five:Within 6 months after PCI plans to accept non cardiac surgery six:Non-compliant patient Follow-up time:A month for 6 months and 9 months to 1 year to 2 years follow-up progress plan:All center within 6 months after start of complete into the group

Detailed Description

no desired

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

800Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
helios stent	Experimental	the group with helios stent implanted	Device: helios stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
helios stent	Device	the group with helios stent implanted	helios stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1 year incidence of target lesion	Target blood vessels caused by cardiac death and myocardial infarction and ischemia driven overall incidence of target lesion revascularization	1year

Secondary Outcomes

Measure	Description	Time Frame
cardiac death Target blood vessels caused by myocardial infarction Ischemia driven target lesion revascularization of 1 year and 2 years,MACE, Stent thrombosis events,clinical success.	Death and myocardial infarction and thromboembolism events and hospitalizations and the incidence of major adverse cardiac events as the standard for safety evaluation	2 years

Other Outcomes

Measure	Description	Time Frame
Rehospitalization rate	Stent placement in patients with the incidence of hospitalized again	2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any age 18 to 80 sex Myocardial ischemia or angina pectoris of coronary artery disease An application stents diameter stenosis greater than 50% Comply with the instructions Voluntarily signed the informed consent form

Exclusion Criteria:

Pregnant women cardiac shock Intolerance to antithrombotic therapy or allergies 6 months prior to the start of the study involved in other studies Within 6 months after PCI plans to accept non cardiac surgery Non-compliant patient

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yan chai hospital affiliated to Shanghai jiaotong university school of medicine	Recruiting	Shanghai	Shanghai Municipality	200127	China

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided