NCT05787886

Brief Summary

The RA-BIA Registry is a single-center observational study. The study included consecutive patients from 2008 who met inclusion criteria and were treated with RA. The main aim of the study is to assess the efficacy of rotational atherectomy.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
15.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

15.7 years

First QC Date

March 15, 2023

Last Update Submit

June 18, 2024

Conditions

Ischemic Heart DiseaseAcute Coronary Syndrome

Keywords

rotational atherectomyrotablation

Outcome Measures

Primary Outcomes (1)

  • Rate of various endpoints

    1\. Rate of the device-oriented composite end point (DOCE) defined as a composite of cardiac death, target Lesion Revascularization (TLR), and target vessel MI), Target Vessel Revascularization (TVR), myocardial infraction (MI), and cardiac death.

    5 years

Secondary Outcomes (1)

  • Procedural, Technical and Clinical Success

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with coronary artery disease who were treated with rotational atherectomy.

You may qualify if:

  • Patient ≥ 18 years old
  • Lesions in target vessels requiring RA
  • Patient accepting the appropriate follow-up as per study definition

You may not qualify if:

  • Patient age \< 18 years
  • Patients who previously participated in this study.
  • Pregnant and/or breastfeeding females or females who intend to become pregnant.
  • Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) .
  • The subject has an allergy to imaging contrast media which cannot be adequately pre-medicated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital

Bialystok, 15-276, Poland

Location

MeSH Terms

Conditions

Myocardial IschemiaAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 28, 2023

Study Start

May 1, 2007

Primary Completion

December 31, 2022

Study Completion

December 31, 2025

Last Updated

June 21, 2024

Record last verified: 2024-06

Locations

PL(1)