Evaluation of Practices and Prognostic Factors of Percutaneous Coronary Interventions (PCI) of Calcified Complex Lesions Using Rotational Atherectomy Device.
NCT ID: NCT03673254
Last Updated: 2021-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1026 participants
OBSERVATIONAL
2016-11-04
2019-01-25
Brief Summary
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Observational studies demonstrate that moderate or severe calcifications in lesions to treat are associated with an increase in mortality, in myocardial infarctions, in stent thrombosis, and in complementary revascularizations. Rotational atherectomy is now part of therapeutic armamentarium of interventional cardiologists for the treatment of some complex calcified coronary lesions. Last recommendations of the European Society of Cardiology about revascularizations indicate that rotational atherectomy should be used for "the preparation of calcified or massive fibrotic lesions that cannot be crossed by a balloon or for an optimal dilatation before stenting". However, this technique is not frequently used and limited to high-volume PCI centers. Even though rotational atherectomy demonstrated an improvement in immediate success of complex lesions, the longterm reduction of cardiovascular events after active stenting has not been proved. In observational studies, the results are not consistent because of many selection biases that influence the choice of an angioplasty with rotational atherectomy device (calcifications, severity of the disease). Furthermore, this technique needs operators with a certain amount of experience. The fundamentals of an optimal use of rotational atherectomy remain to be defined (duration and speed of burr, anti-platelet treatments...).
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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rotational atherectomy device
angioplasty with rotational atherectomy device on a nonselected population
Eligibility Criteria
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Inclusion Criteria
* agree to participate in this study
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Didier CARRIE, MD
Role: PRINCIPAL_INVESTIGATOR
Univesity Hospital Toulouse
Locations
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Hanush Krankenhaus
Vienna, , Austria
La clinique des eaux claires
Grenoble, , France
Les Nouvelles Cliniques Nantaises
Nantes, , France
University Hospital Nimes
Nîmes, , France
University Hospital Toulouse
Toulouse, , France
Augusta Krankenhaus
Düsseldorf, , Germany
St Luke's Hospital
Thessaloniki, , Greece
Azienda Sanitaria Universitaria Integrata di Udine
Udine, , Italy
University of Verona
Verona, , Italy
University Hospital of Bialystok
Bialystok, , Poland
Interventional Cardiology Clinic, Jagiellonina University
Krakow, , Poland
University Hospital in Poznan
Poznan, , Poland
Wojskowy Szpital Kliniczny Wroclaw
Wroclaw, , Poland
Moscow, , Russia
Hospital Del mar
Barcelona, , Spain
Hospital Universitario Central de la Defensa "Gomez Ulla"
Madrid, , Spain
Countries
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Other Identifiers
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RC31/16/8373
Identifier Type: -
Identifier Source: org_study_id