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NCT Number: NCT07471087

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

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

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Key information

Conditions

Peripheral Artery Disease (PAD) Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Critical Limb-Threatening Ischemia Femoropopliteal Artery Disease Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases Vascular Lesion Preparation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Post-Angioplasty Dissections (PADS)

    Time frame: Perioperative/Periprocedural

    Incidence and severity (all grades and severe types C-F) of dissections following balloon angioplasty.

  2. Bailout Stenting Rate

    Time frame: Perioperative/Periprocedural

    Proportion of lesions requiring rescue stent placement after balloon angioplasty.

  3. Device Success / Failure of Chocolate Balloon

    Time frame: During procedure

    Incidence of balloon failure or damage during lesion preparation with the Chocolate PTA balloon.

  4. Clinical Improvement (Rutherford Category)

    Time frame: 1, 6, and 12 months follow-up

    Change in Rutherford category to evaluate clinical improvement in limb ischemia symptoms.

  5. Major Adverse Events (MAE) and Safety

    Time frame: 12 months from index procedure

    Incidence of any major adverse events, including death, amputation, or re-intervention, recorded throughout follow-up.

  6. Final Evaluation at 12 Months

    Time frame: 12 months from index procedure

    Overall assessment of procedural outcomes, vessel patency, safety, and clinical improvement at the end of the follow-up period.

Study contacts

Contact information is provided by the study sponsor or research team.

Felice Pecoraro, Study Coordinator

CONTACT

[email protected]

+390916552715

Sponsors and collaborators

Lead sponsor

Felice Pecoraro

Other

Registry information

Official study 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.

Acronym: CHOICE

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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