# LEADERS FREE II: BioFreedom™ Pivotal Study

> **NCT02843633** · NA · ACTIVE_NOT_RECRUITING · sponsor: **Biosensors Europe SA** · enrollment: 1203 (actual)

## Conditions studied

- Acute Coronary Syndrome
- High Bleeding Risk

## Interventions

- **DEVICE:** BioFreedom™ Drug Coated Coronary Stent System
- **DRUG:** Antiplatelet Drug

## Key facts

- **NCT ID:** NCT02843633
- **Lead sponsor:** Biosensors Europe SA
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2017-02-14
- **Primary completion:** 2018-10-11
- **Final completion:** 2021-03
- **Target enrollment:** 1203 (ACTUAL)
- **Last updated:** 2021-02-03


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02843633

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02843633, "LEADERS FREE II: BioFreedom™ Pivotal Study". Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/clinical/NCT02843633. Licensed CC0.

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