NCT04011527

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
80mo left

Started Nov 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress78%
Nov 2002Dec 2032

Study Start

First participant enrolled

November 25, 2002

Completed
16.6 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Last Updated

June 6, 2022

Status Verified

June 1, 2022

Enrollment Period

28.1 years

First QC Date

June 28, 2019

Last Update Submit

June 3, 2022

Conditions

Coronary Artery Disease

Keywords

Calcified coronary artery lesions

Outcome Measures

Primary Outcomes (1)

  • Rate of in-hospital and long-term cardiovascular adverse events in percent

    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

Study Arms (1)

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

Interventions

Rotational Atherectomy in Coronary Lesion/sPROCEDURE
Patients with Coronary Artery Disease

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herzzentrum Segeberger Kliniken GmbH

Bad Segeberg, 23795, Germany

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Atherectomy, Coronary

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AtherectomyAngioplastyCatheterizationTherapeuticsMyocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeEndovascular ProceduresVascular Surgical ProceduresPercutaneous Coronary InterventionMinimally Invasive Surgical ProceduresThoracic Surgical ProceduresInvestigative Techniques

Study Officials

  • Gert Richardt, Prof., MD

    Herzzentrum Segeberger Kliniken GmbH

    STUDY DIRECTOR

Central Study Contacts

Abdelhakim Allali, MD

CONTACT

+4945512802allali.abdelhakim@gmail.com

Ralph Tölg, P.D., MD

CONTACT

+4945512802ralph.toelg@segebergerkliniken.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2019

First Posted

July 8, 2019

Study Start

November 25, 2002

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2032

Last Updated

June 6, 2022

Record last verified: 2022-06

Locations

DE(1)