Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00568

2 Trial Registration Date

2017-10-31

i Registration Status

Prospective

3 Secondary IDs

CRE-2017.358-T

4 Source(s) of Funding

No

5 Primary Sponsor

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

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Lally Chan

ii Address

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

iii Phone

35051750

iv Email

lallychan@cuhk.edu.hk

v Affiliation

CUHK

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. Bryan Yan

ii Address

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

iii Phone

(852) 2632 3846

iv Email

bryan.yan@cuhk.edu.hk

v Affiliation

Division of Cardiology, Dept. of Medicine and Therapeutics

vi Country

Hong Kong

9 Official Scientific Title of the Study

Optical Coherence Tomography evaluation of Bioabsorbable Vascular Scaffold Technique with Magmaris

10 Public Title

Optical Coherence Tomography evaluation of Bioabsorbable Vascular Scaffold Technique with Magmaris

i Public Title in Chinese 研究名稱

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

11 Short Title (Optional)

OCT-Magmaris

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2017-10-10

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.358-T

14 Medical Condition Being Studied

Coronary artery disease

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

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

iii Dosage form of the intervention

N/A

iv Dosage of the intervention

1.4 microgram/mm2

v Duration of the intervention

12 months

vi Frequency of the intervention

N/A

16 Comparative Treatments

i Description/ name of comparative treatments

N/A

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

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

ii Exclusion Criteria

Subject's physical condition which is contraindicated for coronary angiography

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Other

Please specify

Single arm, cohort study

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-12-05

21 Target Sample Size

30

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Stent strut coverage

ii The metric or method of measurement used

OCT

iii The timepoint(s) of primary interest

1 year after Magmaris implantation

24 Secondary Outcome

i The Name of the outcome

OCT derived percentage stent strut malapposition immediately post-intervention

ii The metric or method of measurement used

OCT

iii The timepoint(s) of primary interest

1 year after Magmaris implantation

Secondary Outcome

i The Name of the outcome

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

ii The metric or method of measurement used

OCT

iii The timepoint(s) of primary interest

1 year after Magmaris implantation

Secondary Outcome

i The Name of the outcome

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)

ii The metric or method of measurement used

OCT

iii The timepoint(s) of primary interest

1 year after Magmaris implantation

Secondary Outcome

i The Name of the outcome

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

ii The metric or method of measurement used

OCT

iii The timepoint(s) of primary interest

1 year after Magmaris implantation

Secondary Outcome

i The Name of the outcome

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

ii The metric or method of measurement used

OCT

iii The timepoint(s) of primary interest

1 year after Magmaris implantation

Secondary Outcome

i The Name of the outcome

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)]

ii The metric or method of measurement used

iii The timepoint(s) of primary interest

1 year after Magmaris implantation

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2018-12-26

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2017-10-31