Evaluation of Practices and Prognostic Factors of Percutaneous Coronary Interventions (PCI) of Calcified Complex Lesions Using Rotational Atherectomy Device.

Completed

• Conditions: Angioplasty

• Registration Number: NCT03673254
• Lead Sponsor: University Hospital, Toulouse

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...).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-04
• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-17
• Primary Completion: 2019-01-25
• Study Completion: 2019-01-25
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1026

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of the prognostic impact of a myocardial	One year	Composite safety endpoint collecting cardiovascular events (cardiovascular death, myocardial infarction, target lesion revascularization, stroke, stent thrombosis, coronary bypass)

Secondary Outcome Measures

Name	Time	Method
Frequency of angiographic complications for an optimization of PCI by rotational atherectomy	one year	Number of angiographic complications
Frequency of in-hospital events	One year	Number of in-hospital events

Trial Locations

Locations (15)

University Hospital Nimes; 🇫🇷 Nîmes, France

University Hospital of Bialystok; 🇵🇱 Białystok, Poland

St Luke's Hospital; 🇬🇷 Thessaloníki, Greece

University Hospital Toulouse; 🇫🇷 Toulouse, France

Les Nouvelles Cliniques Nantaises; 🇫🇷 Nantes, France

La clinique des eaux claires; 🇫🇷 Grenoble, France

Augusta Krankenhaus; 🇩🇪 Dusseldorf, Germany

Hanush Krankenhaus; 🇦🇹 Vienna, Austria

Hospital Del mar; 🇪🇸 Barcelona, Spain

Azienda Sanitaria Universitaria Integrata di Udine; 🇮🇹 Udine, Italy

University of Verona; 🇮🇹 Verona, Italy

University Hospital in Poznan; 🇵🇱 Poznań, Poland

Interventional Cardiology Clinic, Jagiellonina University; 🇵🇱 Kraków, Poland

Wojskowy Szpital Kliniczny Wroclaw; 🇵🇱 Wrocław, Poland

Hospital Universitario Central de la Defensa "Gomez Ulla"; 🇪🇸 Madrid, Spain