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

NCT01880879 | Unknown Phase 4 DMC

• 1 other identifier: Pro-HOPE
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; PCI; stent

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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.

  2 years

• 2 years, the incidence of various combination of the pathological changes of failure

  2 years

Other Outcomes (1)

• Rehospitalization rate

  2 years

Study Arms (1)

helios stent

EXPERIMENTAL

the group with helios stent implanted

Device: helios stent

Interventions

helios stent DEVICE

the group with helios stent implanted

helios stent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kinhely Bio-tech Co., Ltd.: lead
• RenJi Hospital: collaborator
• Peking University: collaborator

Study Sites (1)

Yan chai hospital affiliated to Shanghai jiaotong university school of medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 19, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: June 24, 2013

Record last verified: 2013-01

Locations

CN (1)