In Stent RestenosisIVL-DRAGONNCT05112250
IVL for Stent Underexpantsion
An observational study of In Stent Restenosis and Coronary Artery Calcification, run by Medical University of Silesia at 16 sites in Poland.
Trial summary
The IVL-Dragon Registry was a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL in high-volume PCI centers. The primary efficacy endpoint was clinical success, defined as a reduction of stent underexpansion to <30% with no evidence of in-hospital device-oriented composite… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- In Stent Restenosis, Coronary Artery Calcification, Intravascular Lithotripsy
- What is being tested?
- Percutaneous Coronary Intervention
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- 16 sitesPoland
- Study dates
- 1 Nov 2019to 1 Apr 2021
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: consecutive patients with stent underexpansion treated with intravascular lithotripsy (IVL)
Who may be able to join
- stent underexpansion treated with intravascular lithotripsy (IVL)
Who cannot join
- no
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Poland16 sites
Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital
Bialystok
First Department of Cardiology, Medical University of Gdansk
Gdansk
Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
Katowice, 40-635
Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland
Krakow
Miedziowe Centrum Zdrowia S.A.
Lubin
Department of Cardiology, University Hospital, Institute of Medical Sciences
Opole
Department of Cardiology, Poznan University of Medical Sciences
Poznan
Department of Cardiology
Poznan
Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow
Rzeszów
1st Department of Cardiology, Medical University of Warsaw
Warsaw
Department of Cardiology and Internal Diseases, Military Institute of Medicine
Warsaw
Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland
Warsaw
Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration
Warsaw
Department of Invasive Cardiology, Wejherowo
Wejherowo
Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University
Wroclaw
Third Department of Cardiology, Medical University of Katowice
Zabrze
About this study
Official title: Intravascular Lithotripsy for the Treatment of Stent Underexpansion: the Multicenter IVL-DRAGON Registry
The IVL-Dragon Registry was a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL in high-volume PCI centers. The primary efficacy endpoint was clinical success, defined as a reduction of stent underexpansion to <30% with no evidence of in-hospital device-oriented composite end point (DOCE) (defined as a composite of cardiac death, target lesion revascularization, and target vessel myocardial infarction).
- Being tested
- Percutaneous Coronary Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary InterventionDevice
Intravascular lithotripsy (IVL)
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
Reduction of stent underexpansion to the value of <30% with no evidence of in-hospital device-oriented composite end point (DOCE)
Measured: 30 days
Secondary outcomes (1)
DOCE
composite of cardiac death, target lesion revascularization (TLR), target lesion revascularization, (TLR), and target vessel myocardial infarction (MI)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Nov 2019
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Stent RestenosisStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 62 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Collaborators
- Wojciech Wojakowski
- Responsible party
- Principal investigator, Wojciech Wańha, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112250
- Sponsor's protocol ID
- 06
- Acronym
- IVL-DRAGON
- Status last verified
- Nov 2021
- First submitted
- 19 Oct 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Lithotripsy for the Treatment of Stent Underexpansion: the Multicenter IVL-DRAGON Registry
- ClinicalTrials.gov ID
- NCT05112250
- Acronym / sponsor ID
- IVL-DRAGON / 06
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Collaborators
- Wojciech Wojakowski
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 8 Nov 2021 (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.
The IVL-Dragon Registry was a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL in high-volume PCI centers. The primary efficacy endpoint was clinical success, defined as a reduction of stent underexpansion to <30% with no evidence of in-hospital device-oriented composite end point (DOCE) (defined as a composite of cardiac death, target lesion revascularization, and target vessel myocardial infarction).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- consecutive patients with stent underexpansion treated with intravascular lithotripsy (IVL)
Key inclusion criteria (1 listed)
- stent underexpansion treated with intravascular lithotripsy (IVL)
Key exclusion criteria (1 listed)
- no
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 |
|---|---|---|
| Percutaneous Coronary InterventionIntravascular lithotripsy (IVL) | Device | – |
Primary outcome
Clinical Success
Time frame: 30 days
Reduction of stent underexpansion to the value of <30% with no evidence of in-hospital device-oriented composite end point (DOCE)
1 secondary outcome
DOCE
Time frame: 30 days
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 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of In Stent Restenosis and Coronary Artery Calcification, run by Medical University of Silesia at 16 sites in Poland.
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 1 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 Nov 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 Poland. 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?
Clinical Success (time frame: 30 days). 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 Nov 2021.