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DEB vs Thin-DES in DES-ISR: Long Term Outcomes (DEB Dragon Registry)

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).

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04415216
Acronym
DEB-DRAGON
Enrollment
1369
Registered
2020-06-04
Start date
2019-10-10
Completion date
2020-03-01
Last updated
2021-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In Stent Restenosis

Brief 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. We aimed to evaluate comparing the efficacy and safety profile of DEB and thin-DES in DES-ISR.

Interventions

DEVICEpercutaneous coronary intervention

Percutaneous coronary intervention with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR)

Sponsors

Wojciech Wojakowski
CollaboratorUNKNOWN
Medical University of Silesia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Inclusion criteria

• All consecutive patients with DES-ISR who were treated with either paclitaxel-DEB or thin-DES.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
TLR3 yearstarget lesion revascularisation

Secondary

MeasureTime frameDescription
DOCE3 yearscomposite of cardiac death, TLR, and target vessel MI
TVR3 yearstarget vessel revascularization
TV-MI3 yearstarget vessel myocardial infarction
cardiac death3 years
myocardial infarction3 years

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026