Critical Limb-Threatening Ischemia, Femoropopliteal Artery Disease, Peripheral Artery Disease (PAD), Vascular Lesion Preparation
Conditions
Keywords
Peripheral Artery Disease, Femoropopliteal Lesions, Drug-Coated Balloon, Balloon Angioplasty, vessel preparation
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
Interventions
DEVICEChocolate 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.
DEVICEStandard 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
Felice Pecoraro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency at 12 Months | 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. |
| Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) at 12 Months | 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. |
| Assisted Primary Patency at 12 Months | 12 months from index procedure | Proportion of lesions that remain patent without requiring bailout stenting within 12 months after the index procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-Angioplasty Dissections (PADS) | Perioperative/Periprocedural | Incidence and severity (all grades and severe types C-F) of dissections following balloon angioplasty. |
| Bailout Stenting Rate | Perioperative/Periprocedural | Proportion of lesions requiring rescue stent placement after balloon angioplasty. |
| Device Success / Failure of Chocolate Balloon | During procedure | Incidence of balloon failure or damage during lesion preparation with the Chocolate PTA balloon. |
| Clinical Improvement (Rutherford Category) | 1, 6, and 12 months follow-up | Change in Rutherford category to evaluate clinical improvement in limb ischemia symptoms. |
| Major Adverse Events (MAE) and Safety | 12 months from index procedure | Incidence of any major adverse events, including death, amputation, or re-intervention, recorded throughout follow-up. |
| Final Evaluation at 12 Months | 12 months from index procedure | Overall assessment of procedural outcomes, vessel patency, safety, and clinical improvement at the end of the follow-up period. |
Contacts
CONTACTFelice Pecoraro, Study Coordinator
Outcome results
None listed