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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Kinhely Bio-tech Co.,Ltd..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01880879
First Posted: June 19, 2013
Last Update Posted: June 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
RenJi Hospital
Peking University
Information provided by (Responsible Party):
Kinhely Bio-tech Co.,Ltd.
May 30, 2013
June 19, 2013
June 24, 2013
January 2013
January 2015   (Final data collection date for primary outcome measure)
1 year incidence of target lesion [ Time Frame: 1year ]
Target blood vessels caused by cardiac death and myocardial infarction and ischemia driven overall incidence of target lesion revascularization
  • 1 year target lesion of the failure [ Time Frame: Jan 3rd,2013-Oct 8th,2015 ]
  • Target Lesion Failure [ Time Frame: 1year ]
  • The number of cases of cardiac death and target blood vessels lead to myocardial infarction, number of cases and ischemia driven target lesion reascularization the sum of the number of cases [ Time Frame: 1 year ]
Complete list of historical versions of study NCT01880879 on ClinicalTrials.gov Archive Site
  • 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. [ Time Frame: 2 years ]
    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 [ Time Frame: 2 years ]
    Cardiac death drive target blood vessels lead to myocardial infarction and ischemia of the incidence of target lesion revascularization
  • cardiac death Target blood vessels caused by myocardial infarction Ischemia driven target lesion reascularization of 1 year and 2 years,MACE, Stent thrombosis events,clinical success. [ Time Frame: 2 years ]
  • 1 year and 2 years of target lesion failure combination,MACE,Stent thrombosis events,clinical success. [ Time Frame: 2 years ]
  • The number of cases of cardiac death and target blood vessels lead to myocardial infarction, number of cases and ischemia driven target lesion reascularization the sum of the number of cases [ Time Frame: 2 years ]
Rehospitalization rate [ Time Frame: 2 years ]
Stent placement in patients with the incidence of hospitalized again
  • Rehospitalization rate [ Time Frame: 2 years ]
  • Death, nonfatal acute myocardial infarction, stent thrombosis events and hospitalizations in all the sum total of the number of cases of the revascularization [ Time Frame: 1 year ]
 
A Prospective Multicenter Trial Evaluating Helios Biodegradable Polymer SES Safety and Effectiveness in CAD Treatment
A Prospective Multicenter Trial Evaluating Helios Biodegradable Polymer Sirolimus-eluting Stent Safety and Effectiveness in Treatment of Coronary Artery Disease

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

no desired
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Coronary Artery Disease
Device: helios stent
the group with helios stent implanted
Experimental: helios stent
the group with helios stent implanted
Intervention: Device: helios stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
800
January 2015
January 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01880879
Pro-HOPE
Yes
Not Provided
Not Provided
Kinhely Bio-tech Co.,Ltd.
Kinhely Bio-tech Co.,Ltd.
  • RenJi Hospital
  • Peking University
Not Provided
Kinhely Bio-tech Co.,Ltd.
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP