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

NCT03673254 | Completed

• 1 other identifier: RC31/16/8373
• Study Type: observational
• Target: 1,026
• Locations: 8 countries
• Sites: 16

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...).

Conditions

Angioplasty

Keywords

rotational atherectomy device,

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Frequency of angiographic complications for an optimization of PCI by rotational atherectomy

  one year

• Frequency of in-hospital events

  One year

Interventions

rotational atherectomy device DEVICE

angioplasty with rotational atherectomy device on a nonselected population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (16)

Hanush Krankenhaus

Vienna, Austria

Location

La clinique des eaux claires

Grenoble, France

Location

Les Nouvelles Cliniques Nantaises

Nantes, France

Location

University Hospital Nimes

Nîmes, France

Location

University Hospital Toulouse

Toulouse, 31059, France

Location

Augusta Krankenhaus

Düsseldorf, Germany

Location

St Luke's Hospital

Thessaloniki, Greece

Location

Azienda Sanitaria Universitaria Integrata di Udine

Udine, Italy

Location

University of Verona

Verona, Italy

Location

University Hospital of Bialystok

Bialystok, Poland

Location

Interventional Cardiology Clinic, Jagiellonina University

Krakow, Poland

Location

University Hospital in Poznan

Poznan, Poland

Location

Wojskowy Szpital Kliniczny Wroclaw

Wroclaw, Poland

Location

Unknown Facility

Moscow, Russia

Location

Hospital Del mar

Barcelona, Spain

Location

Hospital Universitario Central de la Defensa "Gomez Ulla"

Madrid, Spain

Location

Study Officials

• Didier CARRIE, MD

  Univesity Hospital Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 17, 2018
• Study Start: November 4, 2016
• Primary Completion: January 25, 2019
• Study Completion: January 25, 2019
• Last Updated: December 8, 2021

Record last verified: 2021-12

Locations

AU (1); RU (1); GR (1); IT (2); PL (4); ES (2); FR (4); DE (1)