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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Kinhely Bio-tech Co.,Ltd.
Sponsor:
Collaborators:
RenJi Hospital
Peking University
Information provided by (Responsible Party):
Kinhely Bio-tech Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01880879
First received: May 30, 2013
Last updated: June 20, 2013
Last verified: January 2013

May 30, 2013
June 20, 2013
January 2013
January 2015   (final data collection date for primary outcome measure)
1 year incidence of target lesion [ Time Frame: 1year ] [ Designated as safety issue: No ]
Target blood vessels caused by cardiac death and myocardial infarction and ischemia driven overall incidence of target lesion revascularization
  • Target Lesion Failure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • 1 year target lesion of the failure [ Time Frame: Jan 3rd,2013-Oct 8th,2015 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • 1 year and 2 years of target lesion failure combination,MACE,Stent thrombosis events,clinical success. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Rehospitalization rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Stent placement in patients with the incidence of hospitalized again
  • Rehospitalization rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Recruiting
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
Both
18 Years to 80 Years
No
China
 
NCT01880879
Pro-HOPE
Yes
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