Clinical trial NCT03673254: Evaluation of Practices and Prognostic Factors of Percutaneous Coronary Interventions (PCI) of Calcified Complex Lesions Using Rotational Atherectomy Device.
Official title: A Prospective Multinational European Study on Evaluation of Practices and Prognostic Factors of Percutaneous Coronary Interventions (PCI) of Calcified Complex Lesions Using Rotational Atherectomy Device.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angioplasty
Keywords: rotational atherectomy device,
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 1026
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Will be included all patients who undergo an angioplasty that requires the rotational atherectomy device and who agree to participate in this study.

Brief summary: In spite of technological advances, PCI of complex calcified coronary lesions remain a challenge.

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...).


Eligibility criteria: Inclusion Criteria:

* patients with angioplasty that requires the rotational atherectomy device
* agree to participate in this study

Exclusion Criteria:

* none

Primary outcomes:
measure: Determination of the prognostic impact of a myocardial
timeFrame: One year
Secondary outcomes:
measure: Frequency of angiographic complications for an optimization of PCI by rotational atherectomy
timeFrame: one year
measure: Frequency of in-hospital events
timeFrame: One year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Hanush Krankenhaus
city: Grenoble
country: France
facility: La clinique des eaux claires
city: Nantes
country: France
facility: Les Nouvelles Cliniques Nantaises
city: Nîmes
country: France
facility: University Hospital Nimes
city: Toulouse
country: France
facility: University Hospital Toulouse
city: Dusseldorf
country: Germany
facility: Augusta Krankenhaus
city: Thessaloníki
country: Greece
facility: St Luke's Hospital
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Integrata di Udine
city: Verona
country: Italy
facility: University of Verona
city: Białystok
country: Poland
facility: University Hospital of Bialystok
city: Kraków
country: Poland
facility: Interventional Cardiology Clinic, Jagiellonina University
city: Poznań
country: Poland
facility: University Hospital in Poznan
city: Wrocław
country: Poland
facility: Wojskowy Szpital Kliniczny Wroclaw
city: Moscow
country: Russian Federation
city: Barcelona
country: Spain
facility: Hospital Del mar
city: Madrid
country: Spain
facility: Hospital Universitario Central de la Defensa "Gomez Ulla"
Study officials:
affiliation: Univesity Hospital Toulouse
name: Didier CARRIE, MD
role: PRINCIPAL_INVESTIGATOR
References: