Evaluation of Practices and Prognostic Factors of Percutaneous Coronary Interventions (PCI) of Calcified Complex Lesions Using Rotational Atherectomy Device. (Eurotaclub)
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| ClinicalTrials.gov Identifier: NCT03673254 |
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Recruitment Status :
Completed
First Posted : September 17, 2018
Last Update Posted : December 8, 2021
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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...).
| Condition or disease | Intervention/treatment |
|---|---|
| Angioplasty | Device: rotational atherectomy device |
| Study Type : | Observational |
| Actual Enrollment : | 1026 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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. |
| Actual Study Start Date : | November 4, 2016 |
| Actual Primary Completion Date : | January 25, 2019 |
| Actual Study Completion Date : | January 25, 2019 |
- Device: rotational atherectomy device
angioplasty with rotational atherectomy device on a nonselected population
- Determination of the prognostic impact of a myocardial [ Time Frame: One year ]Composite safety endpoint collecting cardiovascular events (cardiovascular death, myocardial infarction, target lesion revascularization, stroke, stent thrombosis, coronary bypass)
- Frequency of angiographic complications for an optimization of PCI by rotational atherectomy [ Time Frame: one year ]Number of angiographic complications
- Frequency of in-hospital events [ Time Frame: One year ]Number of in-hospital events
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- patients with angioplasty that requires the rotational atherectomy device
- agree to participate in this study
Exclusion Criteria:
- none
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03673254
| Austria | |
| Hanush Krankenhaus | |
| Vienna, Austria | |
| France | |
| La clinique des eaux claires | |
| Grenoble, France | |
| Les Nouvelles Cliniques Nantaises | |
| Nantes, France | |
| University Hospital Nimes | |
| Nîmes, France | |
| University Hospital Toulouse | |
| Toulouse, France, 31059 | |
| Germany | |
| Augusta Krankenhaus | |
| Dusseldorf, Germany | |
| Greece | |
| St Luke's Hospital | |
| Thessaloníki, Greece | |
| Italy | |
| Azienda Sanitaria Universitaria Integrata di Udine | |
| Udine, Italy | |
| University of Verona | |
| Verona, Italy | |
| Poland | |
| University Hospital of Bialystok | |
| Białystok, Poland | |
| Interventional Cardiology Clinic, Jagiellonina University | |
| Kraków, Poland | |
| University Hospital in Poznan | |
| Poznań, Poland | |
| Wojskowy Szpital Kliniczny Wroclaw | |
| Wrocław, Poland | |
| Russian Federation | |
| Moscow, Russian Federation | |
| Spain | |
| Hospital Del mar | |
| Barcelona, Spain | |
| Hospital Universitario Central de la Defensa "Gomez Ulla" | |
| Madrid, Spain | |
| Principal Investigator: | Didier CARRIE, MD | Univesity Hospital Toulouse |
| Responsible Party: | University Hospital, Toulouse |
| ClinicalTrials.gov Identifier: | NCT03673254 |
| Other Study ID Numbers: |
RC31/16/8373 |
| First Posted: | September 17, 2018 Key Record Dates |
| Last Update Posted: | December 8, 2021 |
| Last Verified: | December 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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rotational atherectomy device, |