EXCEL-II DES to Treat the Patients With de Novo Coronary... | NCT02027870

Studies
EXCEL-II DES to Treat the Patients With de Novo Coronary Artery Lesions. (CREDIT-III)

NCT02027870

Sponsor

JW Medical Systems Ltd

Status

Completed

Last Update Posted

Apr 26, 2023Actual

Enrollment

625Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

EXCEL-II biodegradable polymer sirolimus-eluting stent

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 8, 2014Actual

Primary Completion Date

Jul 30, 2017Actual

Completion Date

Nov 7, 2019Actual

First Submitted Date

Jan 2, 2014

First Submission Date that Met QC Criteria

Jan 2, 2014

First Posted Date

Jan 6, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2023

Last Update Posted Date

Apr 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study aims to further assess the safety, efficacy and the performance of its delivery system of the new generation Sirolimus-eluting stent of JWMS up to five years.

Detailed Description

A prospective, a single set, multicenter clinical trial;
The primary in situ in patients with coronary heart disease;
The center of: 28 (the actual number of center shall prevail);The plan selected 621 patients;(where the total number of cases in 2.25 mm specification not less than 30 cases, 5 cases each specification of not less than 2.25 mm.)
Clinical follow-up time points: 1 months, 6 months, 12 months and 18 months of a year and 2 years to 5 years follow-up; This test by an independent coronary angiography core laboratories, data management and statistical center, clinical end points to judge committee and clinical monitoring of all relevant clinical and imaging data collecting, sorting, statistical analysis and judgement.All the selected patients within five years continuous follow-up tracking (phone or outpatient follow-up), to observe the happening of adverse events to the forward of the second generation of EXCEL drug-eluting stents (des) system security to make more accurate and credible evaluation.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

625Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EXCEL-II DES		Using EXCEL-II biodegradable polymer sirolimus-eluting stent treating CAD	Device: EXCEL-II biodegradable polymer sirolimus-eluting stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EXCEL-II biodegradable polymer sirolimus-eluting stent	Device	EXCEL-II biodegradable polymer sirolimus-eluting stent implantation	EXCEL-II DES

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Target Lesion Failure(TLF) as the primary endpoint at 12-month	Device-related cardiovascular composite endpoint, including cardiac death, target vessel MI and clinically driven TLR at 12 months post procedure	12months

Secondary Outcomes

Measure	Description	Time Frame
Stent implantation success rate		5 Years
TLF, cardiovascular composite endpoints, ARC defined stent thrombosis		30 days, 6 months, and 2-5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

1.18yrs≤Age≤75yrs . 2..stability and unstable angina pectoris (AP), chronic myocardial infarction (OMI) or confirmed (myocardial ischemia; 3.De novo lesion at native coronary artery(Up to four target lesions). 4.Lesion length ≤60mm. 5.RVD 2.25mm～4.0mm. 6.DS%≥70% by visual estimation. 7.Coronary artery bypass surgery (coronary artery bypass grafting) patients. 8.Subjects are willing to follow the specified requirements follow-up.

9.To understand the purpose of testing, voluntary and signed informed consent, willing to accept the imaging and clinical follow-up of subjects.

Exclusion Criteria:

AMI within 7 days.
Left main lesion, transplant vasculopathy and stent restenosis lesion;
Severe calcified lesion unable to predilate.
The distortion of the stent was hampered by lesions.
NYHA≥Ⅲ or LVEF<35%.
Prior PCI within 1 year.
Pregnancy or lactation, and planning pregnancy or lactation.
Subjects have bleeding tendency or blood coagulation dysfunction or PCI contraindications, or anticoagulant therapy taboo or can't continue to take DAPT at least 1 year.
There are other diseases (such as cancer,malignant tumor ,congestive heart failure,organ transplantation or candidate) or abuse history (alcohol cocaine heroin, etc.), scheme compliance is poor, interference related data explanation or the limited life (< 1 year).
To aspirin heparin clopidogrel cobalt chromium alloy rapamycin PLA polymer contrast agent of one of allergy.
Serious liver and kidney function are not complete subject(ALT and AST were three times greater than the upper limit of normal).
Before enrolling to participate in other clinical trials and not reached the primary endpoint.
Non-compliant subject and could not finish the trial in accordance with the requirements of the subjects.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

the Patients With de Novo Coronary Artery Lesions

Sampling Method

Probability Sample

Name	Affiliation	Role
yaling Han, MD	Shen yang Northern hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Shenyang Northern Hospital		Shenyang	Liaoning	110015	China

ID	Term
D003324	Coronary Artery Disease

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Description

According to the CREATE (Multi - Center Registry of Excel Biodegradable Polymer Drug Eluting Stent) registration results show that ExcelTM drug-eluting stents implanted an average of 12 months, target lesion (TLF) the failure rate of 6.7%.Will this study expected target lesion group stent failure rate estimate of 6.7%, the target is 9.5%;Test hypothesis: bilateral 0.05% 0.05%, master degree, clinical follow-up requirements is more than 95%, this research need at least 829 patients, remove the CREDIT II randomized controlled study can provide the number of cases of test group 208 examples, this study still need to be included in the 621 patients.