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

Angioplasty Clinical Trial

— Eurotaclub  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03673254
• Other study ID #: RC31/16/8373
• Status: Completed
• Start date: November 4, 2016
• Est. completion date: January 25, 2019

Study information

• Verified date: December 2021
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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...).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1026
• Est. completion date: January 25, 2019
• Est. primary completion date: January 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with angioplasty that requires the rotational atherectomy device

• agree to participate in this study

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Angioplasty

Intervention

Device:
• rotational atherectomy device
angioplasty with rotational atherectomy device on a nonselected population

Locations

Country	Name	City	State
Austria	Hanush Krankenhaus	Vienna
France	La clinique des eaux claires	Grenoble
France	Les Nouvelles Cliniques Nantaises	Nantes
France	University Hospital Nimes	Nîmes
France	University Hospital Toulouse	Toulouse
Germany	Augusta Krankenhaus	Dusseldorf
Greece	St Luke's Hospital	Thessaloníki
Italy	Azienda Sanitaria Universitaria Integrata di Udine	Udine
Italy	University of Verona	Verona
Poland	University Hospital of Bialystok	Bialystok
Poland	Interventional Cardiology Clinic, Jagiellonina University	Kraków
Poland	University Hospital in Poznan	Poznan
Poland	Wojskowy Szpital Kliniczny Wroclaw	Wroclaw
Spain	Hospital Del mar	Barcelona
Spain	Hospital Universitario Central de la Defensa "Gomez Ulla"	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Countries where clinical trial is conducted

Austria,  France,  Germany,  Greece,  Italy,  Poland,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency of angiographic complications for an optimization of PCI by rotational atherectomy	Number of angiographic complications	one year
Secondary	Frequency of in-hospital events	Number of in-hospital events	One year