NCT05787886

Unknown

Rotational Atherectomy: Long-term Results From a Single Cent...

Medical University of Bialystok Source

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Other study identifiers

Sponsor study identifier

UMB-KKI-105

Study Type

observational

Estimated enrollment

1,200

Locations

1 country

Sites

1

Timeline

Study Start

May 1, 2007

Actual (reported)

Primary Completion

December 31, 2022

Actual (reported)

Study Completion

December 31, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 1,200 participants
Study completion date: December 31, 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
May 1, 2007
Actual (reported)
Primary Completion
December 31, 2022
Actual (reported)
First Submitted
March 15, 2023
Actual (reported)
First Posted
March 28, 2023
Actual (reported)
Study Completion
December 31, 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: June 21, 2024
Status Verified: June 2024
Last Update Submitted: June 18, 2024

Conditions

Acute Coronary Syndrome Ischemic Heart Disease

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

Sponsors & Collaborators

Medical University of Bialystok
Otherlead

Study Sites (1)

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

Bialystok, 15-276, Poland

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

Actual (reported)

Primary Completion

December 31, 2022

Actual (reported)

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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.

Study Completion

December 31, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

June 21, 2024

Record last verified: 2024-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05787886
Data provider: ClinicalTrials.gov
Source updated: 2024-06-21
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:54 UTC

Locations

PL(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations