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

> **NCT02145065** · NA · COMPLETED · sponsor: **Balton Sp.zo.o.** · enrollment: 66 (actual)

## Conditions studied

- Peripheral Artery Disease
- Femoropopliteal Artery Disease

## Interventions

- **DRUG:** Local drug delivery via microcrystalline paclitaxel balloon coating (PAK,Balton, Poland)
- **DEVICE:** Plain balloon angioplasty, uncoated balloon (Neptun, Balton, Poland)

## Key facts

- **NCT ID:** NCT02145065
- **Lead sponsor:** Balton Sp.zo.o.
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2014-09
- **Primary completion:** 2017-09
- **Final completion:** 2017-10
- **Target enrollment:** 66 (ACTUAL)
- **Last updated:** 2018-08-07

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02145065

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02145065, "First-in-man Evaluation of a Novel, Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease (PAX-r)". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT02145065. Licensed CC0.

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