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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Angioplasty Dissections (PADS) | Incidence and severity (all grades and severe types C-F) of dissections following balloon angioplasty. | Perioperative/Periprocedural |
| Bailout Stenting Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Felice Pecoraro, Study Coordinator | Contact | +390916552715 | felice.pecoraro@policlinico.pa.it |
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Individual participant data (IPD) collected in this study will not be made available to other researchers.
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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.
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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.
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|
| 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. |
|
Proportion of lesions requiring rescue stent placement after balloon angioplasty.
| Perioperative/Periprocedural |
| Device Success / Failure of Chocolate Balloon | Incidence of balloon failure or damage during lesion preparation with the Chocolate PTA balloon. | During procedure |
| Clinical Improvement (Rutherford Category) | Change in Rutherford category to evaluate clinical improvement in limb ischemia symptoms. | 1, 6, and 12 months follow-up |
| Major Adverse Events (MAE) and Safety | Incidence of any major adverse events, including death, amputation, or re-intervention, recorded throughout follow-up. | 12 months from index procedure |
| Final Evaluation at 12 Months | Overall assessment of procedural outcomes, vessel patency, safety, and clinical improvement at the end of the follow-up period. | 12 months from index procedure |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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