WithdrawnNot Applicable

DEB Versus 2nd Generation DES in Patients With In-Scaffold Restenosis of Bioresorbable Vascular Scaffold

Stopped: cannot use bioabsorbable scaffold

South Korea0Started 2017-03-08

Plain-language summary

The aim of the study is to compare angiographic outcomes following revascularization using drug-eluting balloon (DEB) versus 2nd generation drug-eluting stent (DES) in treatment of Bioresorbable Vascular Scaffold Restenosis.

Who can participate

Age range19 Years – 85 Years

SexALL

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Inclusion criteria

✓. Visual stenosis ≥50% in ISR segment with typical angina symptom (CCS class ≥II) or positive non-invasive stress tests
✓. ISR lesion with fractional flow reserve (FFR) ≤0.80
✓. Visual stenosis ≥70% in ISR segment (in the absence of above 2 components)

What they're measuring

Minimum lumen diameter (MLD) in BRS ISR lesion, post-PCI

Timeframe: 13-month after index procedure

Trial details

NCT IDNCT03074305

SponsorSamsung Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12-30

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