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The use of heart imaging to study the benefits of a new technique adjustment for treating heart artery narrowing with a stent

Optical coherence tomography to assess proximal side optimization technique

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN23355755
Enrollment
10
Registered
2022-02-13
Start date
2021-01-15
Completion date
Unknown
Last updated
2022-11-07

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

Conditions

Prevention of side branch stent under-expansion during double stent crush percutaneous intervention procedure to treat coronary artery bifurcation lesions Circulatory System

Interventions

10 patients presenting with severe bifurcation stenosis of the LAD-D eligible for two stenting DK Crush procedures, five with proximal side optimization (PSO) modification (control arm), and five DK C

Sponsors

Jilin Heart Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 18 to 75 years old 2. Left anterior descending artery – diagonal branch bifurcation (LAD-D) Medina 1.1.1, with long (>10 mm) and severe stenoses (>75%) of the long (>75 mm) side branch (SB) 3. Undergoing two stent bifurcation PCI with Crush technique

Exclusion criteria

Exclusion criteria: 1. Patients less than 18 years old 2. Cardiogenic shock 3. Renal failure 4. Recent major bleeding 5. Allergy to aspirin or clopidogrel 6. On anticoagulant therapy 7. No suitable anatomy for OCT (extreme tortuosity, very small vessels<2.25 mm in diameter)

Design outcomes

Primary

MeasureTime frame
1. Stent areas in the ostial segment of the side branch and protruding DES areas in the main branch before the side branch stent is crushed, measured with optical coherence tomography (OCT) during the index procedure, after side branch stent implantation 2. Space of optimal wiring (SOW) measured with OCT after crush

Secondary

MeasureTime frame
Gaps in the scaffolding within the ostial segment of the SB DES measured with OCT at the end of the PCI procedure

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026