UMIN-CTR Clinical Trial

Public title

Meta-analysis of BVS and EES: very long term result

Acronym

Meta-analysis of BVS and EES: very long term result

Scientific Title

Meta-analysis of BVS and EES: very long term result

Scientific Title:Acronym

Meta-analysis of BVS and EES: very long term result

Region

Japan

Condition

Coronary Artery Disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Several trials comparing bioabsorbable scaffold (BVS) and everolimus-eluting stent (EES) in patients with coronary artery disease is ongoing, and there are some short-term results stating the risk for acute scaffold thrombosis in the BVS. Besides, the risk for the very late scaffold thrombosis risk, occurring beyond 1-year is unknown, because few studies reported the long-term after BVS implantation, and the number of the enrolled patients in the each study is limited.
Therefore, we conducted a meta-analysis comparing the BVS and the EES regarding stent/scaffold thrombosis and target lesion failure in an attempt to address the very late adverse events of these devices.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Stent/scaffold Thrombosis

Key secondary outcomes

Target Lesion Failure

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

0

years-old

<=

Age-upper limit

150

years-old

>=

Gender

Male and Female

Key inclusion criteria

We searched all reported trials comparing Absorb bioabsorbable vascular scaffold (BVS) and everolimus-eluting stent (EES), and single-arm study evaluated the Absorb BVS or EES, with beyond 1 year results after coronary stent implantation. We identified relevant studies by searching PubMed, the Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, conference proceedings, and presentations from major cardiovascular meetings using the keywords "biosbsorbable", "bioresorbable", "scaffold", "everolimus", and "stent", without language restrictions. We also manually checked reference lists of the identified reports and relevant reviews.
From the gathered studies, randomized controlled trials (RCT) and observational study comparing the effect of Absorb BVS and EES on ST or TLF were extracted. Furthermore, studies evaluated Absorb BVS or everolimus-eluting stent as a single-arm design with the results of ST or TLF with enough 2-year follow up were also extracted to calculate the estimated event rate of the outcome measure between 1 and 2 year from device implantation.

Key exclusion criteria

Studies without enough 2-year follow-up were excluded.

Target sample size

1000

Name of lead principal investigator

1st name
Middle name
Last name	Takeshi Kimura

Organization

Kyoto Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code

Address

54 Shogoinkawaharamachi, Sakyo-ku, Kyoto

TEL

075-751-4255

Email

taketaka@kuhp.kyoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Toshiaki Toyota

Organization

Kyoto Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code

Address

54 Shogoinkawaharamachi, Sakyo-ku, Kyoto

TEL

075-751-4255

Homepage URL

Email

totoyota@kuhp.kyoto-u.ac.jp

Institute

Department of Cardiovascular Medicine, Kyoto Graduate School of Medicine

Institute

Department

Personal name

Organization

Department of Cardiovascular Medicine, Kyoto Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

08

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2016

Year

08

Month

16

Day

Date of IRB

Anticipated trial start date

2016

Year

08

Month

16

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

beyond 1year and 2year result

Registered date

2016

Year

08

Month

28

Day

Last modified on

2016

Year

08

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027424