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Bioflow-DAPT Study

NCT04137510 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1948

Last updated 2024-06-07

No results posted yet for this study

Summary

BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study.

A total of 1'948 subjects will be randomized 1:1 to receive either Orsiro Mission or Resolute Onyx. After index procedure, all patients will receive DAPT (ASA + P2Y12 inhibitor) for 30 days, followed by monotherapy with either P2Y12 inhibitor or ASA only until the end of the study.

Clinical follow-up visits will be scheduled at 1, 6 and 12 months post-procedure.

Conditions

Interventions

DEVICE

Percutaneous coronary intervention

It's a non-surgical procedure that uses a catheter to place a stent into a coronary blood vessel in order to open up the vessel.

Sponsors & Collaborators

  • Biotronik AG

    lead INDUSTRY

Principal Investigators

  • Marco Valgimigli, Prof. Dr. · Cardiocentro Ticino, Via Tesserete 48, 6900 Lugano, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-24
Primary Completion
2022-09-20
Completion
2022-09-20

Countries

  • Australia
  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Italy
  • Latvia
  • Malaysia
  • Netherlands
  • New Zealand
  • Poland
  • Singapore
  • Spain
  • Switzerland
  • Thailand

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 NCT04137510 on ClinicalTrials.gov