MedTrace Logo

Biolimus A9™ (BA9™) Drug Coated Balloon (DCB) Study

NCT04079192 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2022-08-10

No results posted yet for this study

Summary

The study is a Prospective, Randomized, Non-Inferiority Trial to Determine the Safety and Efficacy of the BA9™ Drug Coated Balloon for the Treatment of In-Stent Restenosis. It is a First-in-Man Trial.

Conditions

Interventions

DEVICE

Biolimus A9 Drug Coated Balloon

A non-surgical procedure that uses a catheter to place a semi-compliant angioplasty drug coated balloon to open up coronary arteries that have been narrowed by atherosclerosis. The balloon is inflated to treat the stenosis and transfer the drug to arterial wall, and then is deflated and withdrawn.

DEVICE

SeQuent Please Paclitaxel Drug Coated Balloon

A non-surgical procedure that uses a catheter to place a semi-compliant angioplasty drug coated balloon to open up coronary arteries that have been narrowed by atherosclerosis. The balloon is inflated to treat the stenosis and transfer the drug to arterial wall, and then is deflated and withdrawn.

Sponsors & Collaborators

  • Biosensors Europe SA

    lead INDUSTRY

Principal Investigators

  • Robert A Byrne, MD, PhD · Mater Private Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-08-07
Primary Completion
2023-04-30
Completion
2024-04-30

Countries

  • Germany
  • Ireland
  • Italy
  • Spain
  • United Kingdom

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 NCT04079192 on ClinicalTrials.gov