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Trial History Detail on 2017-12-20

CUHK_CCRB00568

2017-10-31

Prospective

CRE-2017.358-T

No

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

N/A

Not Applicable

Lally Chan

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

35051750

lallychan@cuhk.edu.hk

CUHK

Hong Kong

Prof. Bryan Yan

9/F Lui Che Woio Clinical Sciences Building
Prince of Wales Hospital
Shatin, N.T.
Hong Kong

(852) 2632 3846

bryan.yan@cuhk.edu.hk

Division of Cardiology, Dept. of Medicine and Therapeutics

Hong Kong

Optical Coherence Tomography evaluation of Bioabsorbable Vascular Scaffold Technique with Magmaris

Optical Coherence Tomography evaluation of Bioabsorbable Vascular Scaffold Technique with Magmaris

以光學相干斷層掃描評估 Magmaris 鎂合金全吸收式生物血管支植入術

OCT-Magmaris

Hong Kong

Yes

2017-10-10

Joint CUHK-NTEC Clinical Research Ethics Committee

2017.358-T

Coronary artery disease

Procedure

Implantation of Absorbable Metal Stent (AMS) consisting magnesium alloy (Magmaris)

N/A

1.4 microgram/mm2

12 months

N/A

N/A

N/A

N/A

N/A

N/A

Subject is ≥18 years of age

Subject received Magmaris implantation in Prince of Wale Hospital within 12 months before enrollment

Subject has provided written informed consent

Subject's physical condition which is contraindicated for coronary angiography

18

999

Both Male and Female

Observational

Not Applicable

Not Applicable

Not Applicable

Not Applicable

Other

Single arm, cohort study

2017-12-05

30

Recruiting

Stent strut coverage

OCT

1 year after Magmaris implantation

OCT derived percentage stent strut malapposition immediately post-intervention

OCT

1 year after Magmaris implantation

OCT derived ratio of uncovered to total stent struts per section >30%

OCT

1 year after Magmaris implantation

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)

OCT

1 year after Magmaris implantation

Comparison of the stent strut coverage and malapposition rate with OCT between acute coronary syndrome an stable angina

OCT

1 year after Magmaris implantation

Comparison of the stent strut coverage and malapposition rate with OCT between Magmaris and other drug eluting stent/bare metal stents

OCT

1 year after Magmaris implantation

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)]

1 year after Magmaris implantation

No

2018-12-26

ChiCTR-ONC-17013202

2017-10-31

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