First-in-man Evaluation of a Novel, Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease (PAX-r)

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this pivotal, first in man study will be to evaluate safety and efficacy of the novel, microcrystalline paclitaxel coated balloon (mcPCB, PAK, Balton) in the treatment of femoropopliteal artery disease.

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

Details

• Lead Sponsor: Balton Sp.zo.o.
• Collaborators: American Heart of Poland; American Heart of Poland, Katowice, Poland
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• Age > 18 y.o.

• Claudication in Rutherford Class 1-5,

• Lesion in the femoropopliteal artery defined as >50% and < 99% diameter stenosis with length of up to 10 cm in vessel diameter of 3-7 mm

• Chronic total occlusions of length less than 100 mm

• Ability to cross the lesions with a guidewire.

Exclusion Criteria:

• Critical acute or chronic limb ischemia

• Acute coronary syndrome

• Chronic kidney disease stage III-V

• Restenotic lesion

• Femoropopliteal graft

• Known allergy to clopidogrel or aspirin

• History of stroke within past 6 months

• Age > 80 y.o.

• Life expectancy < 2 years