MedTrace Logo

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

NCT02145065 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2018-08-07

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Local drug delivery via microcrystalline paclitaxel balloon coating (PAK,Balton, Poland)

DEVICE

Plain balloon angioplasty, uncoated balloon (Neptun, Balton, Poland)

Sponsors & Collaborators

  • American Heart of Poland

    collaborator OTHER

  • Balton Sp.zo.o.

    lead INDUSTRY

Principal Investigators

  • Przemysław Nowakowski, M.D., PhD · American Heart of Poland, Katowice, Poland

  • Piotr P Buszman, M.D., PhD · American Heart of Poland, Katowice, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-09-30
Completion
2017-10-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02145065 on ClinicalTrials.gov