Trial Outcomes & Findings for RESOLUTE Japan SVS: The Clinical Evaluation of the MDT-4107 DES in the Treatment of De Novo Lesions in Small Diameter Native Coronary Arteries (NCT NCT01150500)

Last Updated: 2017-03-14

Results Overview

Target Lesion Failure (TLF) at 9 months post-procedure defined as a composite measure of cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven target lesion revascularization (TLR)

Recruitment status

COMPLETED

Study phase

Target enrollment

65 participants

Primary outcome timeframe

9 month

Results posted on

2017-03-14

Participant Flow

In this study the first patient was enrolled in June 2011 and the last patient was enrolled in January 2012 in eleven hospitals in Japan.

There was no significant episode for screening processes.

Participant milestones

Participant milestones
Measure	Stent Placement Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm. MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent
Overall Study STARTED	65
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	65

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RESOLUTE Japan SVS: The Clinical Evaluation of the MDT-4107 DES in the Treatment of De Novo Lesions in Small Diameter Native Coronary Arteries

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stent Placement n=65 Participants Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm. MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	48 Participants n=5 Participants
Age, Continuous	69.4 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants
Region of Enrollment Japan	65 participants n=5 Participants

PRIMARY outcome

Timeframe: 9 month

Population: All 65 patients enrolled were analyzed as intent-to-treat (ITT) population and per protocol(PP) population.

Outcome measures

Outcome measures
Measure	Stent Placement n=65 Participants Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm. MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent
Target Lesion Failure(TLF)	4.62 percentage of TLF

SECONDARY outcome

Timeframe: Baseline and 9 month

Population: 65 patients were analyzed as ITT population

Death, myocardial infarction (Q-wave and non-Q-wave), emergent coronary bypass, or clinically-driven repeat target lesion revascularization by percutaneous surgical methods.

Outcome measures

Outcome measures
Measure	Stent Placement n=65 Participants Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm. MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent
MACE (Major Adverse Cardiac Event)	2 percentage of patient

SECONDARY outcome

Timeframe: Baseline and 9 months

Population: 67 Lesions in 65 patients are analysed.

Defined as the difference between the post-procedure immediate minimal lumen diameter (MLD) and the follow-up angiography MLD at 9 month.

Outcome measures

Outcome measures
Measure	Stent Placement n=65 Participants Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm. MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent
Late Lumen Loss	0.27 mm Standard Deviation 0.33

SECONDARY outcome

Timeframe: Baseline and 9 month

Population: 67 lesions in 65 patients were analysed.

Defined as =\> 50% in-stent diameter stenosis at the follow-up angiogram at 9 month. If an in-stent measurement is not available, the in-lesion diameter was used.

Outcome measures

Outcome measures
Measure	Stent Placement n=65 Participants Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm. MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent
Binary Angiographic Restenosis	1.5 percentage of patient

SECONDARY outcome

Timeframe: 9 month

Population: 67 lesions in 65 patient were analyzed.

The average of two orthogonal views(when possible) of narrowest point within the area of assessment-in lesion, in stent or in segment. minimal luminal diameter is visually estimated during angiography by the investigator; it is measured during quantitative coronary angiography by the Angiographic Core Laboratory.

Outcome measures

Outcome measures
Measure	Stent Placement n=65 Participants Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm. MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent
Minimum Luminal Diameter	1.86 mm Standard Deviation 0.39

SECONDARY outcome

Timeframe: Baseline and 9 month

Population: 67 lesions in 65 patients were analyzed.

The value calculated as 100 x (Reference Vessel Diameter(RVD) - Minimum luminal diameter(MLD))/ RVD using the mean values from orthogonal views (when possible) by quantitative coronary angiography(QCA).

Outcome measures

Outcome measures
Measure	Stent Placement n=65 Participants Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm. MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent
Percent Diameter Stenosis	12.92 % DS (diameter stenosis) Standard Deviation 14.63

SECONDARY outcome

Timeframe: 5 Years

Success (device, lesion, procedure), major adverse cardiac events (MACE), target vessel failure (TVF), and stent thrombosis

Outcome measures

Outcome data not reported

Adverse Events

Stent Placement

Serious events: 16 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Stent Placement n=65 participants at risk Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm. MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent
Cardiac disorders ANGINA PECTORIS	3.1% 2/65 • Number of events 2 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study
Cardiac disorders CARDIAC FAILURE	1.5% 1/65 • Number of events 1 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study
Cardiac disorders CARDIAC FAILURE CONGESTIVE	1.5% 1/65 • Number of events 1 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study
Cardiac disorders CORONARY ARTERY STENOSIS	3.1% 2/65 • Number of events 2 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study
Cardiac disorders MYOCARDIAL INFARCTION	6.2% 4/65 • Number of events 4 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study
Cardiac disorders VENTRICULAR FIBRILLATION	1.5% 1/65 • Number of events 1 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study
Eye disorders CATARCT	1.5% 1/65 • Number of events 1 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study
Gastrointestinal disorders GASTRIC ULCER HAEMORRAGE	1.5% 1/65 • Number of events 1 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study
General disorders MALTI-ORGAN FAILURE	1.5% 1/65 • Number of events 1 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study
Injury, poisoning and procedural complications FEMORAL NECK FRACTURE	1.5% 1/65 • Number of events 1 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study
Injury, poisoning and procedural complications FEMUR FRACTURE	1.5% 1/65 • Number of events 1 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study
Injury, poisoning and procedural complications PELVIC FRACTURE	1.5% 1/65 • Number of events 1 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study
Injury, poisoning and procedural complications ROAD TRAFIC ACCIDENT	1.5% 1/65 • Number of events 1 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study
Musculoskeletal and connective tissue disorders LUMBER SPINAL STENOSIS	1.5% 1/65 • Number of events 1 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study
Nervous system disorders SYNCOPE	1.5% 1/65 • Number of events 1 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study
Renal and urinary disorders RENAL IMPAIRMENT	1.5% 1/65 • Number of events 1 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study
Social circumstances ACTIVITY OF DIALY LIVING IMPAIRED	1.5% 1/65 • Number of events 1 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study
Vascular disorders ATERIOSCLEROSIS OBLITERANS	1.5% 1/65 • Number of events 1 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study

Other adverse events

Other adverse events
Measure	Stent Placement n=65 participants at risk Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm. MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent
Infections and infestations NASOPHARYNGITIS	13.8% 9/65 • Number of events 9 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study
Cardiac disorders ANGINA PECTORIS	6.2% 4/65 • Number of events 4 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study
Cardiac disorders MYOCARDIAL INFARCTION	6.2% 4/65 • Number of events 4 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study
Investigations BLOOD TRIGYCERIES INCREASED	6.2% 4/65 • Number of events 4 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study
Musculoskeletal and connective tissue disorders BACK PAIN	6.2% 4/65 • Number of events 4 • Adverse event (AE) is collected for time between the index procedure and 9 months follow-up.Any serious adverse event (SAE) occurring from the index procedure to 5 year follow-up assessment, regardless of cause, is collected. Major Cardiac Adverse Event (secondary endpoint) is considered " serious " in this study

Additional Information

Hiroko Ookubo

Study Manager

Phone: +81-3-6430-7017

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place