AngioplastyEurotaclubNCT03673254
Evaluation of Practices and Prognostic Factors of Percutaneous Coronary Interventions (PCI) of Calcified Complex Lesions Using Rotational Atherectomy Device.
An observational study of Angioplasty, run by University Hospital, Toulouse at 16 sites in 8 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angioplasty
- What is being tested?
- rotational atherectomy device
- Type of treatment
- Medical device
- How many people
- 1,026 participants
- Where
- 16 sitesin 8 countries
- Study dates
- 4 Nov 2016to 25 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients with angioplasty that requires the rotational atherectomy device
- agree to participate in this study
Who cannot join
- none
Trial locations and contacts
16 sites in 8 countries.
16 sites in 8 countries
France4 sites
La clinique des eaux claires
Grenoble
Les Nouvelles Cliniques Nantaises
Nantes
University Hospital Nimes
Nîmes
University Hospital Toulouse
Toulouse, 31059
Poland4 sites
University Hospital of Bialystok
Bialystok
Interventional Cardiology Clinic, Jagiellonina University
Krakow
University Hospital in Poznan
Poznan
Wojskowy Szpital Kliniczny Wroclaw
Wroclaw
Italy2 sites
Azienda Sanitaria Universitaria Integrata di Udine
Udine
University of Verona
Verona
Spain2 sites
Hospital Del mar
Barcelona
Hospital Universitario Central de la Defensa "Gomez Ulla"
Madrid
About this study
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.
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
- Being tested
- rotational atherectomy device
- Keywords
- rotational atherectomy device,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rotational atherectomy deviceDevice
angioplasty with rotational atherectomy device on a nonselected population
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: One year
Secondary outcomes (2)
Frequency of angiographic complications for an optimization of PCI by rotational atherectomy
Number of angiographic complications
Measured: one year
Frequency of in-hospital events
Number of in-hospital events
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start4 Nov 2016
- Primary completion25 Jan 2019
- Study completion25 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngioplastyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,026 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier CARRIE, MD, Principal investigator, Univesity Hospital Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673254
- Sponsor's protocol ID
- RC31/16/8373
- Acronym
- Eurotaclub
- Status last verified
- Dec 2021
- First submitted
- 12 Sep 2018
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03673254
- Acronym / sponsor ID
- Eurotaclub / RC31/16/8373
- Conditions
- Angioplasty
- Keywords
- rotational atherectomy device,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,026 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 4 Nov 2016 (actual)
- Primary completion
- 25 Jan 2019 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- patients with angioplasty that requires the rotational atherectomy device
- agree to participate in this study
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rotational atherectomy deviceangioplasty with rotational atherectomy device on a nonselected population | Device | – |
Primary outcome
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)
2 secondary outcomes
Frequency of angiographic complications for an optimization of PCI by rotational atherectomy
Time frame: one year
Frequency of in-hospital events
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier CARRIE, MD principal investigator
Univesity Hospital Toulouse
16 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angioplasty, run by University Hospital, Toulouse at 16 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France, Poland, Italy, Spain, Austria and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the prognostic impact of a myocardial (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.