Trial Outcomes & Findings for RESOLUTE Japan - The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent (NCT NCT00927940)
NCT ID: NCT00927940
Last Updated: 2015-05-05
Results Overview
The difference between the post-procedure immediate minimal lumen diameter (MLD) and follow up angigraphy MLD
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Post procedure, 8 Months
Results posted on
2015-05-05
Participant Flow
The first patient and the last patient were enrolled on Mar. 23, 2009 and Oct. 30, 2009 respectively. Total 100 patients were enrolled in this study from 14 sites.
Participant milestones
| Measure |
Zotalolimus Eluting Sttent
All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
99
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Zotalolimus Eluting Sttent
All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
RESOLUTE Japan - The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent
Baseline characteristics by cohort
| Measure |
Zotalolimus Eluting Sttent
n=100 Participants
All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
61 Participants
n=5 Participants
|
|
Age, Continuous
|
67.7 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post procedure, 8 MonthsPopulation: Actually a patient was excluded from this analysis because of death before 30 days follow up.
The difference between the post-procedure immediate minimal lumen diameter (MLD) and follow up angigraphy MLD
Outcome measures
| Measure |
Zotarolimus Eluting Stent
n=99 Participants
100 lesion of 100 ITT patients were subjected for this analysis.
|
|---|---|
|
In-stent Late Lumen Loss (LLL)
|
0.13 mm
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: ITT population
Major Secondary Endpoint Target lesion fature (TLF) is defined as cardiac death, target vessel myocardial infarction(Q wave and non-Q wave), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods.
Outcome measures
| Measure |
Zotarolimus Eluting Stent
n=100 Participants
100 lesion of 100 ITT patients were subjected for this analysis.
|
|---|---|
|
Percent of Patient With Target Lesion Failure(Major Secondary Endpoint)
|
4.0 percentage of participants with TLF
Interval 1.1 to 9.9
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 monthsOutcome measures
Outcome data not reported
Adverse Events
Zotalolimus Eluting Sttent
Serious events: 35 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zotalolimus Eluting Sttent
n=100 participants at risk
All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.
|
|---|---|
|
Cardiac disorders
CORONARY ARTERY RESTENOSIS
|
5.0%
5/100 • 12 months
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
3.0%
3/100 • 12 months
|
|
Cardiac disorders
ANGINA PECTORIS
|
1.0%
1/100 • 12 months
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
1.0%
1/100 • 12 months
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
1.0%
1/100 • 12 months
|
|
Cardiac disorders
IN-STENT CORONARY ARTERY RESTENOSIS
|
1.0%
1/100 • 12 months
|
|
Cardiac disorders
MIOCARDIAL INFARCTION
|
4.0%
4/100 • 12 months
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
1.0%
1/100 • 12 months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.0%
2/100 • 12 months
|
|
Gastrointestinal disorders
COLONIC POLYP
|
1.0%
1/100 • 12 months
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
2.0%
2/100 • 12 months
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HEAMORRAGE
|
2.0%
2/100 • 12 months
|
|
Gastrointestinal disorders
MELAENA
|
1.0%
1/100 • 12 months
|
|
General disorders
PYREXIA
|
1.0%
1/100 • 12 months
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
1.0%
1/100 • 12 months
|
|
Infections and infestations
DIVERTICULITIS
|
1.0%
1/100 • 12 months
|
|
Infections and infestations
PNEUMONIA
|
2.0%
2/100 • 12 months
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
1.0%
1/100 • 12 months
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
1.0%
1/100 • 12 months
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
|
2.0%
2/100 • 12 months
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
1.0%
1/100 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
1.0%
1/100 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTOSIGMOID CANCER
|
1.0%
1/100 • 12 months
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
1.0%
1/100 • 12 months
|
|
Nervous system disorders
DIZZINESS
|
1.0%
1/100 • 12 months
|
|
Psychiatric disorders
DECREASED ACTIVITY
|
1.0%
1/100 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
1.0%
1/100 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISORDER
|
1.0%
1/100 • 12 months
|
|
Surgical and medical procedures
PERCUTANEOUS CORONARY INTERVENTION
|
1.0%
1/100 • 12 months
|
Other adverse events
| Measure |
Zotalolimus Eluting Sttent
n=100 participants at risk
All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.
|
|---|---|
|
Cardiac disorders
CORONARY ARTERY RESTENOSIS
|
6.0%
6/100 • 12 months
|
|
Gastrointestinal disorders
STOMATISIS
|
5.0%
5/100 • 12 months
|
|
General disorders
CHEST DISCONFORT
|
12.0%
12/100 • 12 months
|
|
Infections and infestations
NASOPHARYNGITIS
|
12.0%
12/100 • 12 months
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
5.0%
5/100 • 12 months
|
|
Investigations
ASPARATATE AMINOTRANSFERASE INCREASED
|
8.0%
8/100 • 12 months
|
|
Investigations
BLOOD CREATINE PHOPHOKINASE INCREASED
|
15.0%
15/100 • 12 months
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE MB INCREASED
|
6.0%
6/100 • 12 months
|
|
Investigations
BLOOD PRESSURE DECREASED
|
5.0%
5/100 • 12 months
|
|
Investigations
BLOOD UREA INCREASED
|
6.0%
6/100 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place