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

This study is currently recruiting participants.
Verified January 2013 by Kinhely Bio-tech Co.,Ltd.
Sponsor:
Collaborators:
RenJi Hospital
Peking University Clinical Research Institute
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
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ 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


Other Outcome Measures:
  • Rehospitalization rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01880879

Locations
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    rjluqi@hotmail.com   
Principal Investigator: ben he, chairman         
Sponsors and Collaborators
Kinhely Bio-tech Co.,Ltd.
RenJi Hospital
Peking University Clinical Research Institute
  More Information

Publications:
Responsible Party: Kinhely Bio-tech Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01880879     History of Changes
Other Study ID Numbers: Pro-HOPE
Study First Received: May 30, 2013
Last Updated: June 20, 2013
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014