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

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ClinicalTrials.gov Identifier: NCT04011527
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Segeberger Kliniken GmbH

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

Condition or disease Intervention/treatment
Coronary Artery Disease Procedure: Rotational Atherectomy in Coronary Lesion/s

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: A Prospective Follow-up Assessment in Bad Segeberg With Patients Undergoing a Rotational Atherectomy in Coronary Lesion/s
Actual Study Start Date : November 25, 2002
Estimated Primary Completion Date : December 31, 2030
Estimated Study Completion Date : December 31, 2032

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with coronary artery disease undergoing a rotational atherectomy in coronary lesion/s
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011527


Contacts
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Contact: Abdelhakim Allali, MD +4945512802 ext 4801 abdelhakim.allali@segebergerkliniken.de
Contact: Ralph Tölg, P.D., MD +4945512802 ext 4801 ralph.toelg@segebergerkliniken.de

Locations
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Germany
Herzzentrum Segeberger Kliniken GmbH Recruiting
Bad Segeberg, Germany, 23795
Contact: Gert Richardt, MD    +49 4551 802 4801    gert.richardt@segebergerkliniken.de   
Sponsors and Collaborators
Segeberger Kliniken GmbH
Investigators
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Study Director: Gert Richardt, Prof., MD Herzzentrum Segeberger Kliniken GmbH

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Responsible Party: Segeberger Kliniken GmbH
ClinicalTrials.gov Identifier: NCT04011527     History of Changes
Other Study ID Numbers: SK 111 -- 168/11
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Segeberger Kliniken GmbH:
Calcified coronary artery lesions
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases