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

NCT07471087 | Not Yet Recruiting

• 1 other identifier: POBA_CHOC_RND
• Study Type: interventional
• Target: 242
• Locations: 0 countries
• Sites: N/A

Brief 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

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Post-Angioplasty Dissections (PADS)

  Perioperative/Periprocedural

• Bailout Stenting Rate

  Perioperative/Periprocedural

• Device Success / Failure of Chocolate Balloon

  During procedure

• Clinical Improvement (Rutherford Category)

  1, 6, and 12 months follow-up

• Major Adverse Events (MAE) and Safety

  12 months from index procedure

Study Arms (2)

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.

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.

Device: Standard Balloon Angioplasty (POBA)

Interventions

Chocolate PTA Balloon DEVICE

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.

Chocolate PTA Balloon

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.

Standard Balloon Angioplasty (POBA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Felice Pecoraro: lead

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Felice Pecoraro, Study Coordinator

CONTACT

+390916552715; felice.pecoraro@policlinico.pa.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label trial. No parties are masked. Both the investigators performing the procedure and the participants are aware of the assigned intervention. All procedural and safety outcomes are assessed according to standard practice, and any imaging or clinical follow-up is performed without masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 13, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share