Chocolate Balloon vs Standard Balloon Angioplasty Before Drug-Coated Balloon Treatment for Femoropopliteal Artery Narrowing or Blockage (CHOICE)

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?

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 Overview

• Status: Not yet recruiting
• Conditions: Femoropopliteal Artery Disease; Peripheral Artery Disease (PAD); Critical Limb-Threatening Ischemia; Vascular Lesion Preparation
• Intervention / Treatment: Device: Chocolate PTA Balloon; Device: Standard Balloon Angioplasty (POBA)

• Study Type: Interventional
• Enrollment (Estimated): 242
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Felice Pecoraro, Study Coordinator; Phone Number: +390916552715; Email: felice.pecoraro@policlinico.pa.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chocolate PTA Balloon; 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.	Device: Chocolate PTA Balloon; 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.
Active Comparator: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	12 months from index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Angioplasty Dissections (PADS)	Incidence and severity (all grades and severe types C-F) of dissections following balloon angioplasty.	Perioperative/Periprocedural
Bailout Stenting Rate	Proportion of lesions requiring rescue stent placement after balloon angioplasty.	Perioperative/Periprocedural
Device Success / Failure of Chocolate Balloon	Incidence of balloon failure or damage during lesion preparation with the Chocolate PTA balloon.	During procedure
Clinical Improvement (Rutherford Category)	Change in Rutherford category to evaluate clinical improvement in limb ischemia symptoms.	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.	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.	12 months from index procedure

Collaborators and Investigators

• Sponsor: Felice Pecoraro

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Drug-Coated Balloon; Peripheral Artery Disease; Balloon Angioplasty; Femoropopliteal Lesions; vessel preparation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: POBA_CHOC_RND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) collected in this study will not be made available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No