UnknownNot Applicable

A Comparison Between FFR Guided and CAG Guided Treatment Using DEB in ISR of DES

420 participantsStarted 2020-10-01

Plain-language summary

This is a prospective single center, randomized controlled clinical study aimed to compare the clinical and angiographic follow-up results of patients with in-stent restenosis(ISR) after coronary drug eluting stent(DES) implantation treated by fractional flow reserve -guided and angiography guided drug eluting balloon(DEB) intervention. This study intends to confirm the clinical benefits of optimizing DEB intervention of DES-ISR by FFR.

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.

Exclusion criteria

. ISR in bare metal stents and biodegradable stents
. Complicated with immune diseases
. ISR in left main DES
. Suffer from renal failure requiring dialysis treatment or is undergoing dialysis treatment
. Severe cardiac insufficiency (LVEF \<30%)
. Subjects with ST segment elevation myocardial infarction within 7 days of onset of chest pain
. Pregnant or lactating women
. Combined with other diseases, life expectancy \<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

target vessel failure

Timeframe: 12 month

Trial details

NCT IDNCT04518826

SponsorShanghai Zhongshan Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-10-01

Contact for this trial

Qing Qin, MD

021-64041990 qin.qing@zs-hospital.sh.cn

View on ClinicalTrials.gov More In Stent Restenosis trials