Peripheral Artery Disease (PAD)CHOICENCT07471087
Chocolate Balloon vs Standard Balloon Angioplasty Before Drug-Coated Balloon Treatment for Femoropopliteal Artery Narrowing or Blockage
A study testing Chocolate PTA Balloon and Standard Balloon Angioplasty (POBA) in people with Peripheral Artery Disease (PAD) and Femoropopliteal Artery Disease, run by Felice Pecoraro.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease (PAD), Femoropopliteal Artery Disease, Vascular Lesion Preparation
- What is being tested?
- Chocolate PTA Balloon and Standard Balloon Angioplasty (POBA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Any lesion length
- At least one patent infrapopliteal vessel to the foot
- Expected life expectancy > 12 months
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multicenter Randomized Controlled Trial Comparing Chocolate Percutaneous Transluminal Angioplasty Balloon Versus Plain Old Balloon Angioplasty for Vessel Preparation Prior to Drug-Coated Balloon Treatment in Patients With Femoropopliteal Stenotic or Occlusive Lesions.
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?
Read more
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
- Conditions
- Peripheral Artery Disease (PAD), Femoropopliteal Artery Disease, Vascular Lesion Preparation, Critical Limb-Threatening Ischemia
- Being tested
- Chocolate PTA Balloon, Standard Balloon Angioplasty (POBA)
- Keywords
- Peripheral Artery Disease, Femoropopliteal Lesions, Drug-Coated Balloon, Balloon Angioplasty, vessel preparation
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chocolate PTA BalloonDevice
Participants undergo lesion preparation with the Chocolate Percutaneous Transluminal Angioplasty (PTA) balloon prior to drug-coated balloon (DCB) angioplasty. Procedural outcomes, vessel patency, and safety will be assessed according to standard practice.
Standard Balloon Angioplasty (POBA)Device
Participants undergo lesion preparation with standard plain old balloon angioplasty (POBA) prior to drug-coated balloon (DCB) angioplasty. Procedural outcomes, vessel patency, and safety will be assessed according to standard practice.
| Study group | Role | What they receive |
|---|---|---|
| Chocolate PTA Balloon | Experimental | Participants undergo lesion preparation with the Chocolate Percutaneous Transluminal Angioplasty (PTA) balloon before receiving drug-coated balloon (DCB) angioplasty. Procedural outcomes, vessel patency, and safety will be assessed following standard practice. Receives: Device: Chocolate PTA Balloon |
| Standard Balloon Angioplasty (POBA) | Active comparator | Participants undergo lesion preparation with standard plain old balloon angioplasty (POBA) before receiving drug-coated balloon (DCB) angioplasty. Procedural outcomes, vessel patency, and safety will be assessed following standard practice. Receives: Device: Standard Balloon Angioplasty (POBA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency at 12 Months
Proportion of target femoropopliteal lesions maintaining primary patency without stent placement. Primary patency is defined as PSVR ≤ 2.4 on duplex ultrasound at 12 months.
Measured: 12 months from index procedure
Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) at 12 Months
Proportion of patients who do not require re-intervention on the target lesion within 12 months after the index procedure.
Measured: 12 months from index procedure
Assisted Primary Patency at 12 Months
Proportion of lesions that remain patent without requiring bailout stenting within 12 months after the index procedure.
Measured: 12 months from index procedure
Secondary outcomes (6)
Post-Angioplasty Dissections (PADS)
Incidence and severity (all grades and severe types C-F) of dissections following balloon angioplasty.
Measured: Perioperative/Periprocedural
Bailout Stenting Rate
Proportion of lesions requiring rescue stent placement after balloon angioplasty.
Measured: Perioperative/Periprocedural
Device Success / Failure of Chocolate Balloon
Incidence of balloon failure or damage during lesion preparation with the Chocolate PTA balloon.
Measured: During procedure
Clinical Improvement (Rutherford Category)
Change in Rutherford category to evaluate clinical improvement in limb ischemia symptoms.
Measured: 1, 6, and 12 months follow-up
Major Adverse Events (MAE) and Safety
Incidence of any major adverse events, including death, amputation, or re-intervention, recorded throughout follow-up.
Measured: 12 months from index procedure
Final Evaluation at 12 Months
Overall assessment of procedural outcomes, vessel patency, safety, and clinical improvement at the end of the follow-up period.
Measured: 12 months from index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery Disease (PAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomly assigned to one of two groups using sealed envelopes sent to each study site before the procedure. One group receives lesion preparation with the Chocolate PTA balloon, while the other group receives standard plain old balloon angioplasty. Randomization ensures balanced allocation between groups and minimizes selection bias. Each participant receives only the assigned intervention, followed by drug-coated balloon treatment according to standard practice. Outcomes including procedural success, vessel patency, and safety are then compared between the two parallel groups.
- Masking
- None (open label)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Felice Pecoraro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Felice Pecoraro, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471087
- Sponsor's protocol ID
- POBA_CHOC_RND
- Acronym
- CHOICE
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) collected in this study will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial Comparing Chocolate Percutaneous Transluminal Angioplasty Balloon Versus Plain Old Balloon Angioplasty for Vessel Preparation Prior to Drug-Coated Balloon Treatment in Patients With Femoropopliteal Stenotic or Occlusive Lesions.
- ClinicalTrials.gov ID
- NCT07471087
- Acronym / sponsor ID
- CHOICE / POBA_CHOC_RND
- Conditions
- Peripheral Artery Disease (PAD), Femoropopliteal Artery Disease, Vascular Lesion Preparation, Critical Limb-Threatening Ischemia
- Keywords
- Peripheral Artery Disease, Femoropopliteal Lesions, Drug-Coated Balloon, Balloon Angioplasty, vessel preparation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Felice PecoraroUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are randomly assigned to one of two groups using sealed envelopes sent to each study site before the procedure. One group receives lesion preparation with the Chocolate PTA balloon, while the other group receives standard plain old balloon angioplasty. Randomization ensures balanced allocation between groups and minimizes selection bias. Each participant receives only the assigned intervention, followed by drug-coated balloon treatment according to standard practice. Outcomes including procedural success, vessel patency, and safety are then compared between the two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Chocolate PTA Balloon | Experimental | Device: Chocolate PTA BalloonParticipants undergo lesion preparation with the Chocolate Percutaneous Transluminal Angioplasty (PTA) balloon before receiving drug-coated balloon (DCB) angioplasty. Procedural outcomes, vessel patency, and safety will be assessed following standard practice. |
| Standard Balloon Angioplasty (POBA) | Active comparator | Device: Standard Balloon Angioplasty (POBA)Participants undergo lesion preparation with standard plain old balloon angioplasty (POBA) before receiving drug-coated balloon (DCB) angioplasty. Procedural outcomes, vessel patency, and safety will be assessed following standard practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chocolate PTA BalloonParticipants undergo lesion preparation with the Chocolate Percutaneous Transluminal Angioplasty (PTA) balloon prior to drug-coated balloon (DCB) angioplasty. Procedural outcomes, vessel patency, and safety will be assessed according to standard practice. | Device | Chocolate PTA Balloon |
| Standard Balloon Angioplasty (POBA)Participants undergo lesion preparation with standard plain old balloon angioplasty (POBA) prior to drug-coated balloon (DCB) angioplasty. Procedural outcomes, vessel patency, and safety will be assessed according to standard practice. | Device | Standard Balloon Angioplasty (POBA) |
Primary outcome
Primary Patency at 12 Months
Time frame: 12 months from index procedure
Proportion of target femoropopliteal lesions maintaining primary patency without stent placement. Primary patency is defined as PSVR ≤ 2.4 on duplex ultrasound at 12 months.
Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) at 12 Months
Time frame: 12 months from index procedure
Proportion of patients who do not require re-intervention on the target lesion within 12 months after the index procedure.
Assisted Primary Patency at 12 Months
Time frame: 12 months from index procedure
Proportion of lesions that remain patent without requiring bailout stenting within 12 months after the index procedure.
6 secondary outcomes
Post-Angioplasty Dissections (PADS)
Time frame: Perioperative/Periprocedural
Bailout Stenting Rate
Time frame: Perioperative/Periprocedural
Device Success / Failure of Chocolate Balloon
Time frame: During procedure
Clinical Improvement (Rutherford Category)
Time frame: 1, 6, and 12 months follow-up
Major Adverse Events (MAE) and Safety
Time frame: 12 months from index procedure
Final Evaluation at 12 Months
Time frame: 12 months from index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) collected in this study will not be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Chocolate PTA Balloon and Standard Balloon Angioplasty (POBA) in people with Peripheral Artery Disease (PAD) and Femoropopliteal Artery Disease, run by Felice Pecoraro.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felice Pecoraro, Study Coordinator (+390916552715, felice.pecoraro@policlinico.pa.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency at 12 Months (time frame: 12 months from index procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.