## Protocol Section
### Identification Module
**NCT ID:** NCT01880879

**Acronym:** Pro-HOPE

**Brief Title:** A Prospective Multicenter Trial Evaluating Helios Biodegradable Polymer SES Safety and Effectiveness in CAD Treatment

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

#### Organization Study ID Info
**ID:** Pro-HOPE
#### Organization
**Class:** INDUSTRY
**Full Name:** Kinhely Bio-tech Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2015-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2013-06-24

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-06-20

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2015-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2013-01

**Status Verified Date:** 2013-01

#### Study First Post Date
**Date:** 2013-06-19
**Type:** ESTIMATED
**Study First Submit Date:** 2013-05-30
**Study First Submit QC Date:** 2013-06-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** RenJi Hospital

**Class:** OTHER

**Name:** Peking University

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Kinhely Bio-tech Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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

**Detailed Description:** no desired

### Conditions Module

**Conditions:**

- Coronary Artery Disease

**Keywords:**

- coronary artery disease

- PCI

- stent

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 800

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** the group with helios stent implanted

**Intervention Names:**

- Device: helios stent

**Label:** helios stent

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- helios stent

**Description:** the group with helios stent implanted

**Name:** helios stent

**Type:** DEVICE

### Outcomes Module

#### Other Outcomes

**Description:** Stent placement in patients with the incidence of hospitalized again

**Measure:** Rehospitalization rate

**Time Frame:** 2 years

#### Primary Outcomes

**Description:** Target blood vessels caused by cardiac death and myocardial infarction and ischemia driven overall incidence of target lesion revascularization

**Measure:** 1 year incidence of target lesion

**Time Frame:** 1year

#### Secondary Outcomes

**Description:** Death and myocardial infarction and thromboembolism events and hospitalizations and the incidence of major adverse cardiac events as the standard for safety evaluation

**Measure:** 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

**Description:** Cardiac death drive target blood vessels lead to myocardial infarction and ischemia of the incidence of target lesion revascularization

**Measure:** 2 years, the incidence of various combination of the pathological changes of failure

**Time Frame:** 2 years

### Eligibility Module

**Eligibility 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

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Email:** rjluqi@hotmail.com

- **Name:** qi lu, chairman

- **Phone:** +86-021-68383364

- **Phone Ext:** 68383006

- **Role:** CONTACT

***Contact 2:***

- **Name:** ben he, chairman

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Yan chai hospital affiliated to Shanghai jiaotong university school of medicine

**State:** Shanghai

**Status:** RECRUITING

**Zip:** 200127

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6549

- Name: Coronary Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003324

- Term: Coronary Artery Disease

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000003327

- Term: Coronary Disease

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21960

- Name: Sirolimus

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
