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Completed

NCT Number: NCT04415216

DEB vs Thin-DES in DES-ISR: Long Term Outcomes (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.

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Key information

Conditions

In Stent Restenosis

Study type

Observational

Primary location

Department of Invasive Cardiology, Medical University of Bialystok, Bialystok, Poland

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous coronary intervention

Device

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

Primary outcomes

  1. TLR

    Time frame: 3 years

    target lesion revascularisation

Secondary outcomes

  1. DOCE

    Time frame: 3 years

    composite of cardiac death, TLR, and target vessel MI

  2. TVR

    Time frame: 3 years

    target vessel revascularization

  3. TV-MI

    Time frame: 3 years

    target vessel myocardial infarction

  4. cardiac death

    Time frame: 3 years

  5. myocardial infarction

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Collaborators

  • Wojciech Wojakowski

Registry information

Official study 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).

Acronym: DEB-DRAGON

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jun 4, 2020
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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