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Effectiveness of Paclitaxel-eluting Balloon Catheter in Patients with Sirolimus-eluting Stent Restenosis

Effectiveness of Paclitaxel-eluting Balloon Catheter in Patients with Sirolimus-eluting Stent Restenosis - Paclitaxel-eluting Balloon for SES Restenosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003754
Enrollment
50
Registered
2010-06-14
Start date
2008-09-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

coronary artery disease

Interventions

Paclitaxel-Eluting PTCA Balloon (SeQuent Please balloon catheter, B. Braun Melsungen AG, Vascular Systems, Berlin, Germany) conventional balloon

Sponsors

Kurashiki Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The patients with ISR after SES implantation with clinical evidence of stable angina. The target lesion had to be the first ISR after SES implantation with the vessel 2.5-3.5mm in diameter.

Exclusion criteria

Exclusion criteria: The lesions in the left main coronary artery, or the ostial, bifurcated, or totally occluded lesions were not regarded as the target lesions. Patients with acute coronary syndrome, severe renal insufficiency (glomerular filtration rate: <30 ml/min), prior stent implantation within 6 months, severe concomitant systemic illness, and conditions likely to preclude follow-up angiography were excluded.

Design outcomes

Primary

MeasureTime frame
late lumen loss

Secondary

MeasureTime frame
the rate of binary restenosis and major adverse cardiac events (MACE)

Countries

Japan

Contacts

Public ContactSeiji Habara

Kurashiki Central Hospital Department of Cardiology

sh10461@kchnet.or.jp+81-86-422-0210

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026