CompletedNot Applicable

Trial of a Novel Paclitaxel-coated Balloon With Citrate Excipient for Restenosis in -Limus Analogue DES

Germany125 participantsStarted 2015-01

Plain-language summary

Hypothesis: Angioplasty with a novel paclitaxel-coated balloon (PCB; Agent, Boston Scientific) with citrate-based excipient will be non-inferior to conventional paclitaxel-coated balloon with iopromide excipient (PCB) for the treatment of coronary restenosis after implantation of limus-analogue drug-eluting stents (DES)

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% restenosis after prior implantation of LES in native coronary vessels.
✓. Written, informed consent by the patient for participation in the study.
✓. In women with childbearing potential a negative pregnancy test is mandatory.

Exclusion criteria

✕. Age \< 18 years
✕. Cardiogenic shock
✕. Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
✕. Target lesion located in the left main trunk or bypass graft.
✕. Target lesion located in small vessel (vessel size \< 2.0 mm)
✕. Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
✕. Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min)
✕. Contraindications to antiplatelet therapy, paclitaxel

What they're measuring

In-segment percent diameter stenosis (%DS)

Timeframe: at 6-8 months

Trial details

NCT IDNCT02367495

SponsorDeutsches Herzzentrum Muenchen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10-25

View on ClinicalTrials.gov More Coronary Restenosis trials