Coronary Artery CalcificationDRAGONNCT06276114
IVL vs ELCA for Stent Underexpantsion (IVL-ELCA DRAGON)
An observational study of Coronary Artery Calcification and Intravascular Lithotripsy, run by Medical University of Silesia at 20 sites in 2 countries.
Trial summary
The IVL- ELCA DRAGON Registry is a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL ora ELCA in high-volume PCI centers. The primary efficacy endpoint was device success (technical success with a final stent expansion ≥ 80%). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Calcification, Intravascular Lithotripsy, Excimer Laser-coronary Atherectomy
- What is being tested?
- Stent Underexpansion
- Type of treatment
- Medical device
- How many people
- 121 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 1 Aug 2020to 31 Oct 2023
- How long will I take part?
- 30 Days
- 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: Patients with underexpanded coronary stent were included regardless of time since stent implantation. Patients who did not undergo intravasuclar imaging during PCI were excluded.
Stent underexpansion as stent expansion of <80% assessed with intravascular imaging (minimum in-stent lumen area divided by average reference lumen area x100%).
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
Poland18 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, Poland
Gdansk
Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
Katowice, 40-635
Jacek Legutko
Krakow
Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland
Krakow
1st Military Hospital in Lublin, Lublin, Poland
Lubin
Department of Cardiology, Copper Health Centre (MCZ)
Lubin
Clinical Department of Interventional Cardiology, Medical University of Lublin
Lublin
Department of Cardiology, University Hospital, Institute of Medical Sciences
Opole
Department of Cardiology, Poznan University of Medical Sciences
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
Italy2 sites
Unit of Structural Interventional Cardiology, Department of Clinical and Experimental Medicine, Careggi University Hospital
Florence
Fabrizio D'Ascenzo
Turin
About this study
Official title: Comparison of Intravascular Coronary Lithotripsy and Excimer Laser Coronary Atherectomy for Severe Stent Underexpansion: the Multicenter IVL- ELCA DRAGON Registry
The IVL- ELCA DRAGON Registry is a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL ora ELCA in high-volume PCI centers.
The primary efficacy endpoint was device success (technical success with a final stent expansion ≥ 80%). Thirty days device-oriented composite endpoint (DOCE: cardiac death, target lesion revascularization, or target vessel myocardial infarction) was the secondary endpoint.
- Conditions
- Coronary Artery Calcification, Intravascular Lithotripsy, Excimer Laser-coronary Atherectomy, Stent Restenosis, Stent Occlusion
- Being tested
- Stent Underexpansion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent UnderexpansionDevice
Stent underexpansion was diagnosed as stent expansion of <80% assessed with intravascular imaging.
| Study group | Role | What they receive |
|---|---|---|
| Consecutive patients with stent underexpantsion treated with IVL | Not described Receives: Device: Stent Underexpansion | |
| Consecutive patients with stent underexpantsion treated ELCA | Not described Receives: Device: Stent Underexpansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint was device success
Technical success with a final stent expansion ≥80%.
Measured: During procedure
Secondary outcomes (1)
Device-oriented composite endpoint (DOCE)
cardiac death, target lesion revascularization, or target vessel myocardial infarction
Measured: Thirty days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Aug 2020
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery CalcificationStudies 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
- 121 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wojciech Wańha, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276114
- Sponsor's protocol ID
- 07
- Acronym
- DRAGON
- Status last verified
- Feb 2024
- First submitted
- 18 Feb 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wanha W, Tomaniak M, Wanczura P, Bil J, Januszek R, Wolny R, Opolski MP, Kuzma L, Janas A, Figatowski T, Gasior P, Milewski M, Roleder-Dylewska M, Lewicki L, Kulczycki J, Wlodarczak A, Tomasiewicz B, Iwanczyk S, Sacha J, Koltowski L, Dziarmaga M, Jaguszewski M, Kralisz P, Olajossy B, Sobieszek G, Dyrbus K, Lebek M, Smolka G, Reczuch K, Gil RJ, Dobrzycki S, Kwiatkowski P, Rogala M, Gasior M, Ochala A, Kochman J, Witkowski A, Lesiak M, D'Ascenzo F, Bartus S, Wojakowski W. Intravascular Lithotripsy for the Treatment of Stent Underexpansion: The Multicenter IVL-DRAGON Registry. J Clin Med. 2022 Mar 23;11(7):1779. doi: 10.3390/jcm11071779.
PubMed 35407387
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravascular Coronary Lithotripsy and Excimer Laser Coronary Atherectomy for Severe Stent Underexpansion: the Multicenter IVL- ELCA DRAGON Registry
- ClinicalTrials.gov ID
- NCT06276114
- Acronym / sponsor ID
- DRAGON / 07
- Conditions
- Coronary Artery Calcification, Intravascular Lithotripsy, Excimer Laser-coronary Atherectomy, Stent Restenosis, Stent Occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 23 Feb 2024 (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- ELCA DRAGON Registry is a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL ora ELCA in high-volume PCI centers.
The primary efficacy endpoint was device success (technical success with a final stent expansion ≥ 80%). Thirty days device-oriented composite endpoint (DOCE: cardiac death, target lesion revascularization, or target vessel myocardial infarction) was the secondary endpoint.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Consecutive patients with stent underexpantsion treated with IVL | – | Device: Stent Underexpansion |
| Consecutive patients with stent underexpantsion treated ELCA | – | Device: Stent Underexpansion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with underexpanded coronary stent were included regardless of time since stent implantation. Patients who did not undergo intravasuclar imaging during PCI were excluded.
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 |
|---|---|---|
| Stent UnderexpansionStent underexpansion was diagnosed as stent expansion of <80% assessed with intravascular imaging. | Device | Consecutive patients with stent underexpantsion treated ELCA, Consecutive patients with stent underexpantsion treated with IVL |
Primary outcome
The primary efficacy endpoint was device success
Time frame: During procedure
Technical success with a final stent expansion ≥80%.
1 secondary outcome
Device-oriented composite endpoint (DOCE)
Time frame: Thirty 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 23 Feb 2024.
- Background: PubMed 35407387Wanha W, Tomaniak M, Wanczura P, Bil J, Januszek R, Wolny R, Opolski MP, Kuzma L, Janas A, Figatowski T, Gasior P, Milewski M, Roleder-Dylewska M, Lewicki L, Kulczycki J, Wlodarczak A, Tomasiewicz B, Iwanczyk S, Sacha J, Koltowski L, Dziarmaga M, Jaguszewski M, Kralisz P, Olajossy B, Sobieszek G, Dyrbus K, Lebek M, Smolka G, Reczuch K, Gil RJ, Dobrzycki S, Kwiatkowski P, Rogala M, Gasior M, Ochala A, Kochman J, Witkowski A, Lesiak M, D'Ascenzo F, Bartus S, Wojakowski W. Intravascular Lithotripsy for the Treatment of Stent Underexpansion: The Multicenter IVL-DRAGON Registry. J Clin Med. 2022 Mar 23;11(7):1779. doi: 10.3390/jcm11071779.
- 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.
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Calcification and Intravascular Lithotripsy, run by Medical University of Silesia at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Poland, Italy. 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?
The primary efficacy endpoint was device success (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06276114, which also lists 1 linked publication.
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 23 Feb 2024.