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

NCT02027870 | Completed DMC

• 1 other identifier: CREDIT-III-131113
• Study Type: observational
• Target: 625
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

DES; CAD; EXCEL-II; JWMS; PCI

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• Stent implantation success rate

  5 Years

• TLF, cardiovascular composite endpoints, ARC defined stent thrombosis

  30 days, 6 months, and 2-5 years

Study Arms (1)

EXCEL-II DES

Using EXCEL-II biodegradable polymer sirolimus-eluting stent treating CAD

Device: EXCEL-II biodegradable polymer sirolimus-eluting stent

Interventions

EXCEL-II biodegradable polymer sirolimus-eluting stent DEVICE

EXCEL-II biodegradable polymer sirolimus-eluting stent implantation

EXCEL-II DES

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

the Patients With de Novo Coronary Artery Lesions

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• JW Medical Systems Ltd: lead

Study Sites (1)

Shenyang Northern Hospital

Shenyang, Liaoning, 110015, China

Location

Biospecimen

Retention: NONE RETAINED

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.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• yaling Han, MD

  Shen yang Northern hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2014
• First Posted: January 6, 2014
• Study Start: January 8, 2014
• Primary Completion: July 30, 2017
• Study Completion: November 7, 2019
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

CN (1)