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The Effects of Predilation with Scoring Balloon Compared to Conventional Balloon on Everolimus-eluting Stent Expansion Analyzed with Optical Coherent Tomography

The Effects of Predilation with Scoring Balloon Compared to Conventional Balloon on Everolimus-eluting Stent Expansion Analyzed with Optical Coherent Tomography - Scoring Compared to Conventional Ballooning on Everolimus-eluting Stent Expansion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014176
Enrollment
60
Registered
2014-06-06
Start date
2013-01-01
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

Non-calcified coronary artery atherosclerotic lesions (calcification &lt
50% of circumference) predilated with semi-compliant conventional balloon followed by a single 2.5-3.0 mm Cobalt-chromium Everolimus-eluting stent deployment under optical coherent tomography (OCT) gu
50% of circumference) predilated with semi-compliant Scoring balloon followed by a single 2.5-3.0 mm Cobalt-chromium Everolimus-eluting stent deployment under optical coherent tomography (OCT) guidanc

Sponsors

Nishiarai Heart Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Consecutive patients undergoing staged PCI in a single cardiovascular center. (i) Referential vessel diameter estimated by OCT ((prox.+dist.)/2): 2.5-3.0 mm (ii) Lesion that is able to be covered by a single stent (iii) Lesion with calcification less than 50% of circumference

Exclusion criteria

Exclusion criteria: (i) Acute coronary syndrome (ii) Pregnant patients (iii) Patients with malignant neoplasm whose life expectancies of less than 6 months (iv) Patients underwent prior PCI/CABG within 6 months (v) Patients with decompensated heart failure (vi) Patients with chronic kidney disease > stage 4 (vii) Patients with allergic reaction against ASA or clopidogrel

Design outcomes

Primary

MeasureTime frame
Rate of achieved to predicted stent area after deployment measured by optical coherent tomography (OCT)

Secondary

MeasureTime frame
i) Binary stent restenosis at remote phase (QCA) ii) Target vessel diameter/area after balloon angioplasty (OCT) iii) All-cause mortality, MACE (Major Adverse Cardiac Event)

Countries

Japan

Contacts

Public ContactKentaro Jujo

Nishiarai Heart Center Hospital Department of Cardiology

juken1123@hotmail.co.jp+81358380730

Outcome results

None listed

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