Safety and Efficacy of POT PTCA Balloon Dilatation Catheter for the Optimal Dilation After DES Im… (NCT05368129) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of POT PTCA Balloon Dilatation Catheter for the Optimal Dilation After DES Implantation
China48 participantsStarted 2022-06-08
Plain-language summary
The objective of this randomized control trial is to gain clinical insight on the use of POT PTCA balloon dilatation catheter for the optimal dilation after drug-eluting stent implantation.
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
. Provision of informed consent prior to any study specific procedures;
. Men and women 18 years and older;
. Patients with asymptomatic myocardial ischemia, stable or unstable angina, or acute myocardial infarction with symptoms lasting more than 12 hours;
. The target lesions was de novo lesion;
. Reference vessel diameter of target lesion is between 2.25-4.0mm, and the lesion length is less than 15mm(visual inspection);
. Diameter stenosis of target lesion diameter ≥70% or ≥50%(visual) with ischemia evidence;
. DES was successfully implanted in target lesions;
. TIMI 3 blood flow of target vessel before post-dilation.
Exclusion criteria
. Subjects had clinical symptoms and/or ECG changes consistent with ST-elevation myocardial infarction within 12 hours;
. Allergies to concomitant medications required by the balloon/stent system or protocol used in the study;
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.
1This trial studied a specific PTCA balloon catheter called POT for optimizing stent expansion after a drug-eluting stent is placed — can you explain what 'optimal dilation' means in my case and whether the technique tested here would apply to my coronary artery disease treatment?
2The trial measured 'minimal stent area' as its main outcome — can you help me understand why that measurement matters for my long-term outcomes, and whether how well my stent expands affects my risk of future blockages?
3Since this trial is now completed, has the data been published or shared yet, and would the findings change how you approach my stent procedure compared to what you're already planning?
4This study was listed as Phase NA, which often means it's evaluating a device or technique rather than a drug — does that affect how confident you are in the safety and effectiveness of this specific balloon catheter for my situation?
5Are there standard stent optimization techniques already in use that you would compare to what this trial was testing, and how would you decide which approach is best for my particular coronary anatomy?
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
1
Minimal stent area
Timeframe: through PCI procedure completion
Trial details
NCT IDNCT05368129
SponsorNanjing First Hospital, Nanjing Medical University