Safety and Effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter Co… (NCT07109479) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter Combined With the Intravascular Lithotripsy Therapy Device
China180 participantsStarted 2025-10-01
Plain-language summary
The FORWARD IVL trial is a Prospective, Multicenter Study conducted to assess the safety and effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter combined with the Intravascular Lithotripsy Therapy Device for the pre-treatment of calcified, stenotic de novo coronary artery lesions .
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
. Target lesion is de novo calcified stenotic coronary lesion with no prior intervention.
. Target lesion reference vessel diameter is 2.5-4.0 mm.
. Target lesion meets ONE of the following:
. Guidewire positioned in the true lumen distal to the target lesion and not in the subintimal space prior to device use.
Exclusion criteria
. Unprotected left main coronary artery disease (stenosis \>50%).
. Serious angiographic complication in the target vessel prior to study device use.
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
1
Rate of Device Success
Timeframe: immediately after IVL intervention
2
Freedom from Major Adverse Cardiovascular Events (MACE) within 30 days post-procedure
Timeframe: 30-day after the procedure
Trial details
NCT IDNCT07109479
SponsorSpectrumedics Medical Technology(Shanghai)Co.,Ltd