In Stent RestenosisDEB-DRAGONNCT04415216
DEB vs Thin-DES in DES-ISR: Long Term Outcomes (DEB Dragon Registry)
An observational study of In Stent Restenosis, run by Medical University of Silesia at 9 sites in Poland.
Trial summary
Data regarding the usefulness of percutaneous coronary intervention (PCI) with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR) in every day clinical practice is scarce. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- In Stent Restenosis
- What is being tested?
- percutaneous coronary intervention
- Type of treatment
- Medical device
- How many people
- 1,369 participants
- Where
- 9 sitesPoland
- Study dates
- 10 Oct 2019to 1 Mar 2020
- How long will I take part?
- 3 Years
- 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
- Child, Adult, Older adult
Study population: Patients with DES-ISR who were treated with either paclitaxel-DEB or thin-DES
Who may be able to join
- All consecutive patients with DES-ISR who were treated with either paclitaxel-DEB or thin-DES.
Who cannot join
- PCI with DES struts thickness >100μm
- PCI with DEB and thin-DES in the same procedure
- PCI of other vascular territories during the same procedure
- PCI in saphenous vain graft or internal mammary artery
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Poland9 sites
Department of Invasive Cardiology, Medical University of Bialystok
Bialystok, 15-089
Cardiovascular Institute, Nicolaus Copernicus University, Bydgoszcz, Poland
Bydgoszcz
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
Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland
Krakow
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
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: Long-term Outcomes Following Drug Eluting Balloon Versus Thin Struts Drug Eluting Stents for Treating In-stent Restenosis: Propensity Score-matched Analysis(DEB-Dragon Registry).
Data regarding the usefulness of percutaneous coronary intervention (PCI) with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR) in every day clinical practice is scarce. We aimed to evaluate comparing the efficacy and safety profile of DEB and thin-DES in DES-ISR.
- Conditions
- In Stent Restenosis
- 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
Percutaneous coronary intervention with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR)
| Study group | Role | What they receive |
|---|---|---|
| ISR PCI with thin-DES | Not described Receives: Device: percutaneous coronary intervention | |
| ISR PCI with DEB | Not described Receives: Device: percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
TLR
target lesion revascularisation
Measured: 3 years
Secondary outcomes (5)
DOCE
composite of cardiac death, TLR, and target vessel MI
Measured: 3 years
TVR
target vessel revascularization
Measured: 3 years
TV-MI
target vessel myocardial infarction
Measured: 3 years
cardiac death
Measured: 3 years
myocardial infarction
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start10 Oct 2019
- Primary completion30 Dec 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 1,369 participants (actual)
- Target duration
- 3 Years
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
- NCT04415216
- Sponsor's protocol ID
- 02
- Acronym
- DEB-DRAGON
- Status last verified
- Sep 2021
- First submitted
- 31 May 2020
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
De Filippo O, Wanha W, Sanavia T, Januszek R, Giacobbe F, Campo G, Pinxterhuis TH, Capodanno D, Tomasiewicz B, Iannaccone M, Leone A, Wolny R, Bruno F, Patti G, Musumeci G, Liccardo G, Verardi R, Roubin SR, Tarantini G, Kuzma L, Perl L, Gagnor A, Reczuch K, Conrotto F, Tuttolomondo D, Ploumen EH, Niezgoda P, Caglioni S, Omede P, Greco A, Kubica J, Gil RJ, Piccolo R, Kornowski R, Bil J, Morena A, Zocca P, Pennone M, Gasior M, Jaguszewski M, von Birgelen C, Fariselli P, De Ferrari GM, Wojakowski W, D'Ascenzo F. Treatment of in-stent restenosis with ultrathin-strut versus thin-strut drug-eluting stents or drug-eluting balloons: a multicentre registry. EuroIntervention. 2024 Nov 4;20(21):e1340-e1354. doi: 10.4244/EIJ-D-24-00491.
PubMed 39492702Wanha W, Bil J, Januszek R, Gilis-Malinowska N, Figatowski T, Milewski M, Pawlik A, Staszczak B, Wybraniec M, Tomasiewicz B, Kubler P, Kuliczkowski W, Walczak T, Hrymniak B, Desperak P, Mielczarek M, Ciecwierz D, Niezgoda P, Wolny R, Chudzik M, Kuzma L, Kralisz P, Kedhi E, D'Ascenzo F, Hudziak D, Kowalowka A, Smolka G, Reczuch K, Gruchala M, Kubica J, Gil RJ, Dobrzycki S, Dudek D, Bartus S, Gasior M, Ochala A, Witkowski A, Jaguszewski M, Wojakowski W. Long-Term Outcomes Following Drug-Eluting Balloons Versus Thin-Strut Drug-Eluting Stents for Treatment of In-Stent Restenosis (DEB-Dragon-Registry). Circ Cardiovasc Interv. 2021 Sep;14(9):e010868. doi: 10.1161/CIRCINTERVENTIONS.121.010868. Epub 2021 Sep 3.
PubMed 34474584
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes Following Drug Eluting Balloon Versus Thin Struts Drug Eluting Stents for Treating In-stent Restenosis: Propensity Score-matched Analysis(DEB-Dragon Registry).
- ClinicalTrials.gov ID
- NCT04415216
- Acronym / sponsor ID
- DEB-DRAGON / 02
- Conditions
- In Stent Restenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,369 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Collaborators
- Wojciech Wojakowski
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 4 Jun 2020 (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.
Data regarding the usefulness of percutaneous coronary intervention (PCI) with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR) in every day clinical practice is scarce. We aimed to evaluate comparing the efficacy and safety profile of DEB and thin-DES in DES-ISR.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ISR PCI with thin-DES | – | Device: percutaneous coronary intervention |
| ISR PCI with DEB | – | Device: percutaneous coronary intervention |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with DES-ISR who were treated with either paclitaxel-DEB or thin-DES
Key inclusion criteria (1 listed)
- All consecutive patients with DES-ISR who were treated with either paclitaxel-DEB or thin-DES.
Key exclusion criteria (4 listed)
- PCI with DES struts thickness >100μm
- PCI with DEB and thin-DES in the same procedure
- PCI of other vascular territories during the same procedure
- PCI in saphenous vain graft or internal mammary artery
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 interventionPercutaneous coronary intervention with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR) | Device | ISR PCI with DEB, ISR PCI with thin-DES |
Primary outcome
TLR
Time frame: 3 years
target lesion revascularisation
5 secondary outcomes
DOCE
Time frame: 3 years
TVR
Time frame: 3 years
TV-MI
Time frame: 3 years
cardiac death
Time frame: 3 years
myocardial infarction
Time frame: 3 years
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 21 Sep 2021.
- Derived from this study: PubMed 39492702De Filippo O, Wanha W, Sanavia T, Januszek R, Giacobbe F, Campo G, Pinxterhuis TH, Capodanno D, Tomasiewicz B, Iannaccone M, Leone A, Wolny R, Bruno F, Patti G, Musumeci G, Liccardo G, Verardi R, Roubin SR, Tarantini G, Kuzma L, Perl L, Gagnor A, Reczuch K, Conrotto F, Tuttolomondo D, Ploumen EH, Niezgoda P, Caglioni S, Omede P, Greco A, Kubica J, Gil RJ, Piccolo R, Kornowski R, Bil J, Morena A, Zocca P, Pennone M, Gasior M, Jaguszewski M, von Birgelen C, Fariselli P, De Ferrari GM, Wojakowski W, D'Ascenzo F. Treatment of in-stent restenosis with ultrathin-strut versus thin-strut drug-eluting stents or drug-eluting balloons: a multicentre registry. EuroIntervention. 2024 Nov 4;20(21):e1340-e1354. doi: 10.4244/EIJ-D-24-00491.
- Derived from this study: PubMed 34474584Wanha W, Bil J, Januszek R, Gilis-Malinowska N, Figatowski T, Milewski M, Pawlik A, Staszczak B, Wybraniec M, Tomasiewicz B, Kubler P, Kuliczkowski W, Walczak T, Hrymniak B, Desperak P, Mielczarek M, Ciecwierz D, Niezgoda P, Wolny R, Chudzik M, Kuzma L, Kralisz P, Kedhi E, D'Ascenzo F, Hudziak D, Kowalowka A, Smolka G, Reczuch K, Gruchala M, Kubica J, Gil RJ, Dobrzycki S, Dudek D, Bartus S, Gasior M, Ochala A, Witkowski A, Jaguszewski M, Wojakowski W. Long-Term Outcomes Following Drug-Eluting Balloons Versus Thin-Strut Drug-Eluting Stents for Treatment of In-Stent Restenosis (DEB-Dragon-Registry). Circ Cardiovasc Interv. 2021 Sep;14(9):e010868. doi: 10.1161/CIRCINTERVENTIONS.121.010868. Epub 2021 Sep 3.
- 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.
9 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, run by Medical University of Silesia at 9 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 4 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 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
TLR (time frame: 3 years). 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 NCT04415216, which also lists 2 linked publications.
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 21 Sep 2021.