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A Prospective Multicenter Trial Evaluating Helios Biodegradable Polymer SES Safety and Effectiveness in CAD Treatment (Pro-HOPE)

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
helios stent
Sponsored by
Kinhely Bio-tech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery disease, PCI, stent

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yan chai hospital affiliated to Shanghai jiaotong university school of medicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

helios stent

Arm Description

the group with helios stent implanted

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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, the incidence of various combination of the pathological changes of failure
Cardiac death drive target blood vessels lead to myocardial infarction and ischemia of the incidence of target lesion revascularization

Full Information

First Posted
May 30, 2013
Last Updated
June 20, 2013
Sponsor
Kinhely Bio-tech Co., Ltd.
Collaborators
RenJi Hospital, Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT01880879
Brief Title
A Prospective Multicenter Trial Evaluating Helios Biodegradable Polymer SES Safety and Effectiveness in CAD Treatment
Acronym
Pro-HOPE
Official Title
A Prospective Multicenter Trial Evaluating Helios Biodegradable Polymer Sirolimus-eluting Stent Safety and Effectiveness in Treatment of Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kinhely Bio-tech Co., Ltd.
Collaborators
RenJi Hospital, Peking University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, PCI, stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
helios stent
Arm Type
Experimental
Arm Description
the group with helios stent implanted
Intervention Type
Device
Intervention Name(s)
helios stent
Intervention Description
the group with helios stent implanted
Primary Outcome Measure Information:
Title
1 year incidence of target lesion
Description
Target blood vessels caused by cardiac death and myocardial infarction and ischemia driven overall incidence of target lesion revascularization
Time Frame
1year
Secondary Outcome Measure Information:
Title
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.
Description
Death and myocardial infarction and thromboembolism events and hospitalizations and the incidence of major adverse cardiac events as the standard for safety evaluation
Time Frame
2 years
Title
2 years, the incidence of various combination of the pathological changes of failure
Description
Cardiac death drive target blood vessels lead to myocardial infarction and ischemia of the incidence of target lesion revascularization
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Rehospitalization rate
Description
Stent placement in patients with the incidence of hospitalized again
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Yan chai hospital affiliated to Shanghai jiaotong university school of medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
qi lu, chairman
Phone
+86-021-68383364
Ext
68383006
Email
rjluqi@hotmail.com
First Name & Middle Initial & Last Name & Degree
ben he, chairman

12. IPD Sharing Statement

Learn more about this trial

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

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