Ultrasound to Enhance Paclitaxel Uptake in Critical Limb Ischemia: the PACUS Trial

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The PACUS Trial was a single center, single blinded, randomized trial designed to evaluate the safety and efficacy of intravascular percutaneous catheter-delivered ultrasound energy to improve local Paclitaxel delivery effects in critical limb ischemia patients due to femoral-popliteal artery disease.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rome Tor Vergata
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• Rutherford category ≥4

• femoral-popliteal lesion ≥10cm

• successful intraluminal recanalization without need of a stent to obtain a satisfactory angiographic result

• at least one patent below the knee vessel

• patients older than 18 years

Exclusion Criteria:

• Rutherford category < 4

• pregnancy

• known allergies to study medications and materials

• need of sub-intimal approach to perform the recanalization

• target vessel stent release