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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
RenJi Hospital
Peking University
Information provided by (Responsible Party):
Kinhely Bio-tech Co.,Ltd. Identifier:
First received: May 30, 2013
Last updated: June 20, 2013
Last verified: January 2013

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

Condition Intervention Phase
Coronary Artery Disease
Device: helios stent
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Trial Evaluating Helios Biodegradable Polymer Sirolimus-eluting Stent Safety and Effectiveness in Treatment of Coronary Artery Disease

Resource links provided by NLM:

Further study details as provided by Kinhely Bio-tech Co.,Ltd.:

Primary Outcome Measures:
  • 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

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. [ 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

Other Outcome Measures:
  • Rehospitalization rate [ Time Frame: 2 years ]
    Stent placement in patients with the incidence of hospitalized again

Estimated Enrollment: 800
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: helios stent
the group with helios stent implanted
Device: helios stent
the group with helios stent implanted

Detailed Description:
no desired

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01880879

China, Shanghai
Yan chai hospital affiliated to Shanghai jiaotong university school of medicine Recruiting
Shanghai, Shanghai, China, 200127
Contact: qi lu, chairman    +86-021-68383364 ext 68383006   
Principal Investigator: ben he, chairman         
Sponsors and Collaborators
Kinhely Bio-tech Co.,Ltd.
RenJi Hospital
Peking University
  More Information

Responsible Party: Kinhely Bio-tech Co.,Ltd. Identifier: NCT01880879     History of Changes
Other Study ID Numbers: Pro-HOPE
Study First Received: May 30, 2013
Last Updated: June 20, 2013

Keywords provided by Kinhely Bio-tech Co.,Ltd.:
coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on April 26, 2017