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Optical Coherence Tomography evaluation of Bioabsorbable Vascular Scaffold Technique with Magmaris

Optical Coherence Tomography evaluation of Bioabsorbable Vascular Scaffold Technique with Magmaris

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-17013202
Enrollment
Unknown
Registered
2017-10-31
Start date
2017-12-05
Completion date
Unknown
Last updated
2019-01-28

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

Conditions

Coronary artery disease

Interventions

Case series:Implantation of Absorbable Metal Stent (AMS) consisting magnesium alloy (Magmaris), 1.4 microgram/mm2 for 12 months

Sponsors

Department of Medicine & Therapeutics, The Chinese University of Hong Kong
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subject is =18 years of age; 2. Subject received Magmaris implantation in Prince of Wale Hospital within 12 months before enrollment; 3. Subject has provided written informed consent.

Exclusion criteria

Exclusion criteria: Subject's physical condition which is contraindicated for coronary angiography

Design outcomes

Primary

MeasureTime frame
Stent strut coverage;

Secondary

MeasureTime frame
OCT derived percentage stent strut malapposition immediately post-intervention;OCT derived ratio of uncovered to total stent struts per section >30%;OCT derived stent area(circumferential area limited by the contours of the struts), lumen area(circumferential dark zone in the center of the struts), neointimal area(calculated by subtracting the lumen area from the stent area) & neointimal thickness(distance between surface of each stent & lumen);Comparison of the stent strut coverage and malapposition rate with OCT between acute coronary syndrome an stable angina;Comparison of the stent strut coverage and malapposition rate with OCT between Magmaris and other drug eluting stent/bare metal stents;Incidence of target lesion failure [TLF, composite of cardiac death, non-fatal myocardial infarction (MI) or target lesion revascularization (TLR) (by PCI or by coronary artery bypass grafting)];

Countries

China

Contacts

Public ContactProf. Bryan Yan

Division of Cardiology, Dept. of Medicine and Therapeutics

bryan.yan@cuhk.edu.hk+852 2632 3846

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026