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

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.

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...).

Study Overview

• Status: Completed
• Conditions: Angioplasty
• Intervention / Treatment: Device: rotational atherectomy device

• Study Type: Observational
• Enrollment (Actual): 1026

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Hanush Krankenhaus
• France
  • Grenoble, France
    • La clinique des eaux claires
  • Nantes, France
    • Les Nouvelles Cliniques Nantaises
  • Nîmes, France
    • University Hospital Nimes
  • Toulouse, France, 31059
    • University Hospital Toulouse
• Germany
  • Dusseldorf, Germany
    • Augusta Krankenhaus
• Greece
  • Thessaloníki, Greece
    • St Luke's Hospital
• Italy
  • Udine, Italy
    • Azienda Sanitaria Universitaria integrata di Udine
  • Verona, Italy
    • University of Verona
• Poland
  • Białystok, Poland
    • University Hospital of Bialystok
  • Kraków, Poland
    • Interventional Cardiology Clinic, Jagiellonina University
  • Poznań, Poland
    • University Hospital in Poznan
  • Wrocław, Poland
    • Wojskowy Szpital Kliniczny Wroclaw
• Russian Federation
  • Moscow, Russian Federation
• Spain
  • Barcelona, Spain
    • Hospital del Mar
  • Madrid, Spain
    • Hospital Universitario Central de la Defensa "Gomez Ulla"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of angiographic complications for an optimization of PCI by rotational atherectomy	Number of angiographic complications	one year
Frequency of in-hospital events	Number of in-hospital events	One year

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Didier CARRIE, MD, Univesity Hospital Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2016
• Primary Completion (Actual): January 25, 2019
• Study Completion (Actual): January 25, 2019

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: rotational atherectomy device,
• Other Study ID Numbers: RC31/16/8373

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No