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

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03673254
Acronym
Eurotaclub
Enrollment
1026
Registered
2018-09-17
Start date
2016-11-04
Completion date
2019-01-25
Last updated
2021-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angioplasty

Keywords

rotational atherectomy device,

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...).

Interventions

DEVICErotational atherectomy device

angioplasty with rotational atherectomy device on a nonselected population

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Determination of the prognostic impact of a myocardialOne yearComposite safety endpoint collecting cardiovascular events (cardiovascular death, myocardial infarction, target lesion revascularization, stroke, stent thrombosis, coronary bypass)

Secondary

MeasureTime frameDescription
Frequency of angiographic complications for an optimization of PCI by rotational atherectomyone yearNumber of angiographic complications
Frequency of in-hospital eventsOne yearNumber of in-hospital events

Countries

Austria, France, Germany, Greece, Italy, Poland, Russia, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026