The Prospective Segeberg Registry for Rotational Atherectomy in Coronary Lesion/s

June 3, 2022 updated by: Segeberger Kliniken GmbH

A Prospective Follow-up Assessment in Bad Segeberg With Patients Undergoing a Rotational Atherectomy in Coronary Lesion/s

A Prospective Follow-up Assessment in Bad Segeberg with Patients undergoing a Rotational Atherectomy in Coronary Lesion/s

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A prospective single center registry including all patients treated with Rotational Atherectomy in Coronary Lesion/s at the Heart Center, Bad Segeberg, Germany. Patients undergo a routine clinical follow-up schedule, including a long-term follow-up.

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with coronary artery disease undergoing a rotational atherectomy in coronary lesion/s

Description

Inclusion Criteria:

  • All patients undergoing a rotational atherectomy of coronary lesion/s

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Coronary Artery Disease
Patients with Coronary Artery Disease undergoing a Rotational Atherectomy in Coronary Lesion/s
Procedure: Rotational Atherectomy in Coronary Lesion/s

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of in-hospital and long-term cardiovascular adverse events in percent
Time Frame: 2 years
Peri-procedural events and in-hospital cardiovascular events and long-term cardiovascular events (bleeding, peripheral and coronary vascular complication, stroke, myocardial infarction, stent thrombosis, revascularization, death)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Segeberger Kliniken GmbH

Investigators

  • Study Director: Gert Richardt, Prof., MD, Herzzentrum Segeberger Kliniken GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2002

Primary Completion (Anticipated)

December 31, 2030

Study Completion (Anticipated)

December 31, 2032

Study Registration Dates

First Submitted

June 28, 2019

First Submitted That Met QC Criteria

July 4, 2019

First Posted (Actual)

July 8, 2019

Study Record Updates

Last Update Posted (Actual)

June 6, 2022

Last Update Submitted That Met QC Criteria

June 3, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SK 111 -- 168/11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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