CompletedNot Applicable

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

China419 participantsStarted 2013-12-08

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓.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 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.

Exclusion criteria

✕. 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.

What they're measuring

9 months in-stent late lumen loss

Timeframe: 9 months

Trial details

NCT IDNCT02057978

SponsorJW Medical Systems Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-10-20

View on ClinicalTrials.gov More Coronary Artery Disease trials