NCT02758847

Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty

Evaluation of Paclitaxel in Patients With CLI (Critical Limb Ischemia) and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Rabih A. Chaer · Academic / Other
• Sex: All
• Age: 40 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The use of drug coated balloon (DCB) in patients with critical limb ischemia (CLI) and tissue loss has recently raised some concerns after the IN.PACT deep trial using paclitaxel coated balloon angioplasty in the tibial arteries was terminated. The investigators objective is to establish the safety and efficacy of drug coated balloon (DCB) for femoropopliteal occlusive disease in patients with critical limb ischemia (CLI) and tissue loss. The investigators objective is to establish the safety and efficacy of drug coated balloon (DCB) for femoropopliteal occlusive disease in patients with critical limb ischemia (CLI) and tissue loss.

Detailed description

Although the association between the drug coated balloon (DCB) therapy and limb outcomes could not be clearly linked to the use of antiproliferative agents, the findings of paclitaxel crystals downstream of the treated lesions, although in small amounts, has raised concerns about the safety of such therapy in patients with critical limb ischemia (CLI) and tissue loss. These concerns, however, may not translate to patients with femoropopliteal occlusive disease as the amount of paclitaxel reaching the foot may be even smaller after being filtered by the calf musculature. Since the use of DCB angioplasty in the Superficial Femoral Artery (SFA) and popliteal has been shown to deliver significantly more durable outcomes compared to standard angioplasty alone, with reported primary patency rates of almost 90% at one year, this therapy may even be more needed in patients with tissue loss where prolonged patency is essential for wound healing.

Conditions

• Ischemia

Interventions

Type	Name	Description
DEVICE	Angiogram, Medtronic DCB (paclitaxel)/stent	Paclitaxel® coated balloons will be used for patients identified with Critical Limb Ischemia (CLI) and Tissue Loss. Each participant will receive angiogram with DCB (drug coated balloon)/stenting with wound debridement. 50% of subjects will receive an Angiogram, Medtronic DCB (paclitaxel)/stent. Tissue samples will be sent to pathology for specific staining to evaluate trace evidence of the drug paclitaxel.
DEVICE	Angiogram, Bard DCB (paclitaxel)/stent	Paclitaxel® coated balloons will be used for patients identified with Critical Limb Ischemia (CLI) and Tissue Loss. 50% of subjects will receive 'Angiogram, Bard DCB (paclitaxel)/stent' . Tissue samples will be sent to pathology for specific staining to evaluate trace evidence of the drug paclitaxel.

Timeline

• Start date: 2016-09-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2016-05-03
• Last updated: 2024-04-25
• Results posted: 2024-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study