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 range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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