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Not yet recruiting NCT07471087

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

No phase Interventional Peripheral Artery Disease (PAD) Femoropopliteal Artery Disease Vascular Lesion Preparation Critical Limb-Threatening Ischemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chocolate PTA Balloon, Standard Balloon Angioplasty (POBA).
Who it may be relevant to
Registry conditions: Peripheral Artery Disease (PAD), Femoropopliteal Artery Disease, Vascular Lesion Preparation, Critical Limb-Threatening Ischemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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

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.

Primary outcome measures

  • Primary Patency at 12 Months [Time frame: 12 months from index procedure]
  • Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) at 12 Months [Time frame: 12 months from index procedure]
  • Assisted Primary Patency at 12 Months [Time frame: 12 months from index procedure]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07471087 · POBA_CHOC_RND

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗