A Prospective Multicenter Trial Evaluating Helios Biodegradable Polymer SES Safety and Effectiveness in CAD Treatment

Coronary Artery Disease Clinical Trial

— Pro-HOPE  

Official title:

A Prospective Multicenter Trial Evaluating Helios Biodegradable Polymer Sirolimus-eluting Stent Safety and Effectiveness in Treatment of Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01880879
• Other study ID #: Pro-HOPE
• Status: Recruiting
• Phase: Phase 4
• First received: May 30, 2013
• Last updated: June 20, 2013
• Start date: January 2013
• Est. completion date: January 2015

Study information

• Verified date: January 2013
• Source: Kinhely Bio-tech Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

no desired

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• helios stent
the group with helios stent implanted

Locations

Country	Name	City	State
China	Yan chai hospital affiliated to Shanghai jiaotong university school of medicine	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Kinhely Bio-tech Co.,Ltd.	Peking University, RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rehospitalization rate	Stent placement in patients with the incidence of hospitalized again	2 years	Yes
Primary	1 year incidence of target lesion	Target blood vessels caused by cardiac death and myocardial infarction and ischemia driven overall incidence of target lesion revascularization	1year	No
Secondary	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.	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	Yes
Secondary	2 years, the incidence of various combination of the pathological changes of failure	Cardiac death drive target blood vessels lead to myocardial infarction and ischemia of the incidence of target lesion revascularization	2 years	No