MedTrace Logo

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

NCT07471087 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2026-03-13

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Felice Pecoraro

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-06-30
Completion
2029-06-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07471087 on ClinicalTrials.gov