Chocolate Balloon vs Standard Balloon Angioplasty Before Drug-Coated Balloon Treatment for Femoro… (NCT07471087) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Chocolate Balloon vs Standard Balloon Angioplasty Before Drug-Coated Balloon Treatment for Femoropopliteal Artery Narrowing or Blockage
242 participantsStarted 2026-06
Plain-language summary
The goal of this clinical trial is to learn if using the Chocolate Percutaneous Transluminal Angioplasty (PTA) balloon for vessel preparation improves outcomes before drug-coated balloon (DCB) treatment in patients with femoropopliteal artery narrowing or blockage. It will also learn about the safety of the Chocolate PTA balloon. The main questions it aims to answer are:
Does using the Chocolate PTA balloon reduce the need for bailout stenting or vessel complications during DCB treatment?
What medical problems do participants have when receiving the Chocolate PTA balloon compared with standard balloon angioplasty?
Researchers will compare the Chocolate PTA balloon to standard plain old balloon angioplasty (POBA) to see if it improves vessel preparation before DCB therapy.
Participants will:
Undergo lesion preparation with either the Chocolate PTA balloon or standard balloon angioplasty, followed by DCB treatment
Have clinical and imaging follow-up visits to assess safety and vessel patency
Report any complications or adverse events throughout the study
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:
* Age ≥ 18 years
* Indication for endovascular revascularization of the femoropopliteal artery
* Rutherford Category 3, 4, or 5
* De novo femoropopliteal lesion
* Stenosis ≥ 70% or chronic total occlusion (CTO)
* Any degree of calcification
* Any lesion length
* At least one patent infrapopliteal vessel to the foot
* Expected life expectancy \> 12 months
Exclusion Criteria:
* Age \< 18 years
* No indication for endovascular revascularization of the femoropopliteal artery
* Rutherford Category 0, 1, 2, or 6
* Restenotic lesion
* Absence of at least one patent infrapopliteal vessel to the foot
* Inability to complete the planned follow-up
* Life expectancy \< 12 months
* Pregnancy
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
Primary Patency at 12 Months
Timeframe: 12 months from index procedure
2
Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) at 12 Months