Comparison of Agent™ and SeQuent® Please Paclitaxel Coated Balloon Catheters in Coronary In-stent… (NCT02151812) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Agent™ and SeQuent® Please Paclitaxel Coated Balloon Catheters in Coronary In-stent Restenosis (AGENT-ISR)
France, Germany123 participantsStarted 2014-08-13
Plain-language summary
The primary objective of this study is determine the safety and performance of the Agent™ Paclitaxel-Coated PTCA Balloon Catheter compared to the SeQuent® Please Paclitaxel-Releasing Coronary Balloon Catheter for the treatment of patients with narrowed previously-stented coronary arteries (in-stent restenosis).
The performance will be determined at six months post-procedure by quantitative coronary angiography (QCA) to measure Late Lumen Loss (LLL) in the re-opened stented segment. QCA results will be assessed by an independent, blinded angiographic core lab.
Study statistical hypothesis: The loss of in-stent luminal diameter at six months after treatment of the restenosed stent with the Agent™ study device is not larger than the respective LLL after treatment with the SeQuent® Please control devices, i.e. study device is non-inferior to the control device with respect to LLL.
Who can participate
Age range
18 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:
* Subject must be at least 18 years of age
* Subject is willing and able to provide informed consent
* Subject is eligible for percutaneous coronary intervention
* Subject is willing to comply with all protocol-required follow-up evaluations
* Women of child-bearing potential must agree to use a reliable method of contraception
* In-stent restenosis in a lesion previously treated with either a drug-eluting or bare metal stent, located in a native coronary artery with a reference vessel diameter ≥ 2.0 mm and ≤ 3.5 mm
* Target lesion length must be ≤ 28 mm (by visual estimate) and must be covered by only one balloon
* Target lesion must have visually estimated stenosis ≥ 70% and \< 100% in asymptomatic patients
* Target lesion must have visually estimated stenosis ≥ 50% and \< 100% in symptomatic patients
* Thrombolysis in Myocardial Infarction (TIMI) grade flow in the target lesion must be ≥ 1
* Target lesion must be successfully pre-dilated.
Exclusion Criteria:
* Patient has life expectancy of less than 24 months
* Patient with known coronary artery spasm
* Patient with unprotected left main coronary artery disease
* Patient has current problems with substance abuse
* Patient has planned procedure that may cause non-compliance with the protocol or confound data interpretation
* Patient is participating in another investigational drug or device clinical study that has not reached its primary endpoint
* Patient intends to participate in another investigat…
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.