EXCEL-II Stent Vesus EXCEL Stent to Treat the Patients With de Novo Coronary Artery Lesions.

NCT02057978 | Completed DMC

• 1 other identifier: CREDIT-II-131105
• Study Type: observational
• Target: 419
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this Randomized Study to evaluate the safety and efficacy of the Excel-II DES compared to the EXCEL DES in the treatment of patients with de novo coronary artery lesions.

Conditions

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

Keywords

Late Lumen Loss; MACE; Death; TLF; Thrombosis(definite or probable )

Outcome Measures

Primary Outcomes (1)

• 9 months in-stent late lumen loss

  To observe in-stent late lumen loss after 9 months of stent implantation

  9 months

Secondary Outcomes (3)

• 9-m in-segment diameter restenosis rate

  9 months

• Device success rates , lesion success rates , clinical success rates Device, lesion, & clinical success rates Device, lesion, & clinical success rates Target Lesion Failure

  1m,6m,9m,12m,18m and annually to 5years

• Rate of stent thrombosis

  1m,6m,9m,12m,18m and annually up to 5 yrs

Study Arms (2)

EXCEL DES

Use EXCEL DES implatationas as control group,Implant DES for CAD cases

Procedure: EXCEL DES implatation

EXCEL-II DES

EXCEL-II DES implantation as control group,Implant DES for CAD cases

Procedure: EXCEL-II DES implantation

Interventions

EXCEL DES implatation PROCEDURE

Implant DES for CAD cases

Also known as: Implant DES for CAD cases

EXCEL DES

EXCEL-II DES implantation PROCEDURE

Implant DES for CAD cases

Also known as: Implant EXCEL-II DES for CAD cases

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

This study will plan for a total of 416 patients with primary, in situ coronary artery lesions (all of the patients was selected in different blood vessels, a total of up to two target disease Variable and each target lesion 1 stents, such as placing stents need more than one in the operation, require the use of the same brand of stents, mix does not recommend the same patients Other brand support, unless save extra stents.) Choose lesions reference diameter of 2.5 mm to 2.5 mm (visual), each lesion length 32 mm or less (visual), participants must conform to the standard can be selected.

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 two target lesions). 4.Lesion length ≤32mm. 5.RVD 2.5mm～4.0mm. 6.DS%≥70% by visual test. 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 the trial and willing to sign informed consent and accept clinical follow-up.

You may not qualify if:

• AMI within 7 days.
• CTO (TIMI 0), the left main lesion, ostial lesion and transplant vascular lesions, the bifurcation lesion (reference collateral blood vessel diameter of 2.5 mm or higher), stent restenosis lesions and to deal with three pathological changes;
• Severe calcified lesion unable to predilate.
• The distortion of the stent was hampered by lesions.
• NYHA≥Ⅲ or LVEF\<40%.
• 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

Related Publications (1)

• Xu K, Han Y, Xu B, Yang Y, Wang G, Li H, Sun Y, Tao L, Wang H, Yuan Z, Liu H, Liu J, Jia Y, Ma G, Fu G, Li X, Li S, Wang S, Pu K; CREDIT 2 Investigators. Efficacy and safety of a second-generation biodegradable polymer sirolimus-eluting stent: One-year results of the CREDIT 2 trial. Cardiovasc Ther. 2018 Jun;36(3):e12327. doi: 10.1111/1755-5922.12327. Epub 2018 Mar 25.

  PMID: 29493880 DERIVED

Biospecimen

Retention: NONE RETAINED

Endpoint Classification: Safety/Efficacy Study Enrollment: 416 cases \[Anticipated\]

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Han Yaling, PhD

  Shenyang Northern Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: February 7, 2014
• Study Start: December 8, 2013
• Primary Completion: October 20, 2017
• Study Completion: December 25, 2019
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

CN (1)