Assessment of Cutting-Balloon Angioplasty with Drug-Eluting Stent in the Treatment of Calcified Coronary Lesions

Assessment of Cutting-Balloon Angioplasty with Novel Bioabsorbable Polymer-Coated, Everolimus-Eluting Stent in the Treatment of Calcified Coronary Lesions Guided by Intravascular Ultrasound

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0009170

Enrollment

250

Registered

2024-02-08

Start date

2024-02-01

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

None listed

Interventions

Medical Device : Intervention group : patients who received PCI with Wolverine cutting balloon to modify calcified coronary lesion Control group : patients who received PCI with Non-compliant balloon

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Coronary artery disease including ISR or de novo lesion with a stenosis of = 70% (2) Target lesion calcification (an arch of calcium at least 100 degrees) was confirmed by imaging studies (3) A reference vessel diameter between 2.5 and 4.0mm and deemed suitable for PCI

Exclusion criteria

Exclusion criteria: (1) Extremely tortuous or angulated lesions (2) Lesions with dissection before balloon pre-dilatation (3) Lesions within the vein graft (4) Extremely narrow lesions which need to rotational atherectomy (5) ST-elevation MI(STEMI) (6) Comorbidities which preclude the achievement of one year follow up

Design outcomes

Primary

Measure	Time frame
Minimal stent cross-section area(CSA) with IVUS at calcium site	—

Secondary

Measure	Time frame
All-cause death ;Cardiovascular death;Myocardial infarction(MI) ;Target vessel revascularization(TVR) ;Target lesion revascularization(TLR) ;Total procedure time of the index procedure;Total amount of contrast used in the index procedure;The total number of balloons used in the index procedure;Major adverse cardiac event(MACE)	—

Countries

Korea, Republic of

Contacts

Public ContactEunbin Park

Soonchunhyang University Medical Center

popori114@naver.com+82-32-621-5114

Outcome results