Trial Outcomes & Findings for Endeavor Zotarolimus - Eluting Stent in the Treatment Lesions in Small Native Coronary Arteries. (NCT NCT00609947)
NCT ID: NCT00609947
Last Updated: 2015-02-09
Results Overview
In-segment percent diameter stenosis at 8 months post-procedure with percent diameter stenosis defined as the value calculated as 100 x (RVD - Minimal Lumen Diameter (MLD)/RVD using the mean values from two orthogonal views (when possible) by Qualitative Coronary Angiography (QCA).
COMPLETED
NA
241 participants
8 months post-procedure
2015-02-09
Participant Flow
Subjects were recruited by local and regional medical centers from December 21, 2007 through November 22, 2010.
Subjects were excluded from participation if they did not meet inclusion/exclusion criteria and fall into the category of per protocol small vessel stenting - 2.25mm, 2.5mm and 2.75mm - single or multi-vessel (Rev K).
Participant milestones
| Measure |
Endeavor Zotarolimus-Eluting Coronary Stent
Zotarolimus-eltuing stent (ZES) implanted using standard percutaneous coronary intervention (PCI) technique via the femoral approach
|
|---|---|
|
Overall Study
STARTED
|
241
|
|
Overall Study
COMPLETED
|
240
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Endeavor Zotarolimus-Eluting Coronary Stent
Zotarolimus-eltuing stent (ZES) implanted using standard percutaneous coronary intervention (PCI) technique via the femoral approach
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Endeavor Zotarolimus - Eluting Stent in the Treatment Lesions in Small Native Coronary Arteries.
Baseline characteristics by cohort
| Measure |
Endeavor Zotarolimus-Eluting Coronary Stent
n=241 Participants
Zotarolimus-eluting stent (ZES) implanted using standard percutaneous coronary intervention (PCI) technique via the femoral approach
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
231 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
156 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
241 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 months post-procedurePopulation: The primary analysis sample consisted of 176 subjects (ITT) including the first 97 subjects with 2.25 mm, 39 subjects with 2.50 mm and 40 subjects with 2.75mm stents who met the study entry criteria, signed the written informed consent, and were enrolled in the trial.
In-segment percent diameter stenosis at 8 months post-procedure with percent diameter stenosis defined as the value calculated as 100 x (RVD - Minimal Lumen Diameter (MLD)/RVD using the mean values from two orthogonal views (when possible) by Qualitative Coronary Angiography (QCA).
Outcome measures
| Measure |
Primary Effectiveness Analysis Endpoint - SVS
n=176 Participants
The 8-month in-segment diameter stenosis from Endeavor Small Vessel Study (SVS) subects
|
|---|---|
|
In-segment Percent Diameter Stenosis at 8 Months Post-procedure
|
37.4 percent diameter stenosis
Interval 16.6 to 58.2
|
PRIMARY outcome
Timeframe: 12 months post-procedurePopulation: 12-month MACE Rate was compared to a 20% performance goal. * 1st 97 subjects enrolled and implanted with 2.25mm stents * 1st 39 subjects enrolled and implanted with 2.5mm stents * 1st 40 subjects enrolled and implanted with 2.75mm stents * A supplemental safety analysis group of subjects with 2.25mm stents N=38 (included in 2.25mm group N=135)
Major Adverse Cardiac Events rate at 12 months post-procedure defined as death, target-vessel Myocardial Infarction (Q wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization, repeat percutaneous transluminal coronary angioplasty or cardiac bypass surgery.
Outcome measures
| Measure |
Primary Effectiveness Analysis Endpoint - SVS
n=241 Participants
The 8-month in-segment diameter stenosis from Endeavor Small Vessel Study (SVS) subects
|
|---|---|
|
Major Adverse Cardiac Events (MACE) Rate
|
10.0 Percentage
Interval 10.0 to 13.8
|
Adverse Events
Primary Analysis Endpoint
Serious adverse events
| Measure |
Primary Analysis Endpoint
n=176 participants at risk
* The first 97 subjects enrolled and implanted with 2.25mm stents
* The first 39 subjects enrolled and implanted with 2.5mm stents
* The first 40 subjects enrolled and implanted with 2.75mm stents
* A supplemental safety analysis group of subjects with 2.25mm stents N=38 (included in 2.25mm group N=135)
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
2/176 • Number of events 87 • 1 Year
|
|
Cardiac disorders
Accute myocardial infarction
|
1.7%
3/176 • Number of events 87 • 1 Year
|
|
Cardiac disorders
angina pectoris
|
5.7%
10/176 • Number of events 87 • 1 Year
|
|
Cardiac disorders
angina unstable
|
2.3%
4/176 • Number of events 87 • 1 Year
|
|
Cardiac disorders
Atrial Fibrillation
|
1.7%
3/176 • Number of events 87 • 1 Year
|
|
Cardiac disorders
Bradycardia
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Cardiac disorders
Cardiac failure congestive
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Cardiac disorders
Coronary artery disease
|
3.4%
6/176 • Number of events 87 • 1 Year
|
|
Cardiac disorders
Coronary artery dissection
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Cardiac disorders
Coronary artery occlusion
|
2.3%
4/176 • Number of events 87 • 1 Year
|
|
Cardiac disorders
Cronary artery restenosis
|
1.1%
2/176 • Number of events 87 • 1 Year
|
|
Cardiac disorders
Coronary artery stenosis
|
6.2%
11/176 • Number of events 87 • 1 Year
|
|
Cardiac disorders
In-stent coronary artery restenosis
|
9.1%
16/176 • Number of events 87 • 1 Year
|
|
Cardiac disorders
Myocardial infarction
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Cardiac disorders
Ventricular tachycardia
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.8%
5/176 • Number of events 87 • 1 Year
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Gastrointestinal disorders
Retroperitoneal Haemorrhage
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Gastrointestinal disorders
Vomiting
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
General disorders
chest discomfort
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
General disorders
Chest pain
|
9.1%
16/176 • Number of events 87 • 1 Year
|
|
General disorders
Injection site haematoma
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
General disorders
Non-cardiac chest pain
|
2.3%
4/176 • Number of events 87 • 1 Year
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Infections and infestations
Cellulitis
|
1.1%
2/176 • Number of events 87 • 1 Year
|
|
Infections and infestations
Infected skin ulcer
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Infections and infestations
Infection
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Infections and infestations
Pneumonia
|
2.8%
5/176 • Number of events 87 • 1 Year
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Injury, poisoning and procedural complications
injury
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Injury, poisoning and procedural complications
Pocket erosion
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Investigations
Blood creatinine increased
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Metabolism and nutrition disorders
diabetes mellitus inadequate control
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Nervous system disorders
Cerebrovascular accident
|
1.1%
2/176 • Number of events 87 • 1 Year
|
|
Nervous system disorders
Syncope
|
1.7%
3/176 • Number of events 87 • 1 Year
|
|
Nervous system disorders
Transient ischaemic attack
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Psychiatric disorders
Depression
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Renal and urinary disorders
Renal failure
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.7%
3/176 • Number of events 87 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
3/176 • Number of events 87 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.1%
2/176 • Number of events 87 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Vascular disorders
Embolism
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Vascular disorders
Hypertension
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Vascular disorders
Hypotension
|
1.1%
2/176 • Number of events 87 • 1 Year
|
|
Vascular disorders
Intermittent claudication
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Vascular disorders
Lymphoedema
|
0.57%
1/176 • Number of events 87 • 1 Year
|
|
Vascular disorders
Peripheral ischaemia
|
0.57%
1/176 • Number of events 87 • 1 Year
|
Other adverse events
Adverse event data not reported
Additional Information
Lynda Chaplin - Study Manager
Medtronic CardioVascular
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place