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
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

No publications provided

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 September 16, 2014