Trial Outcomes & Findings for PROTECT Continued Access Post Marketing Surveillance Trial (NCT NCT00846846)
NCT ID: NCT00846846
Last Updated: 2015-05-04
Results Overview
The primary endpoint rate of ARC-defined definite or probable stent thrombosis at 3 years.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1018 participants
Primary outcome timeframe
3 years
Results posted on
2015-05-04
Participant Flow
1018 patients were enrolled from February 2009 until November 2009 in 48 participating hospitals in USA.
Subjects were excluded from participation if they did not meet inclusion/exclusion criteria.
Participant milestones
| Measure |
Endeavor® Zotarolimus Eluting Coronary Stent System
Endeavor® Zotarolimus Eluting Coronary Stent System\>
\> Endeavor® Zotarolimus Eluting Coronary Stent System: Endeavor® Zotarolimus Eluting Coronary Stent System in a patient population requiring stent implantation
|
|---|---|
|
Overall Study
STARTED
|
1018
|
|
Overall Study
COMPLETED
|
943
|
|
Overall Study
NOT COMPLETED
|
75
|
Reasons for withdrawal
| Measure |
Endeavor® Zotarolimus Eluting Coronary Stent System
Endeavor® Zotarolimus Eluting Coronary Stent System\>
\> Endeavor® Zotarolimus Eluting Coronary Stent System: Endeavor® Zotarolimus Eluting Coronary Stent System in a patient population requiring stent implantation
|
|---|---|
|
Overall Study
Death
|
56
|
|
Overall Study
Withdrawal by Subject
|
19
|
Baseline Characteristics
PROTECT Continued Access Post Marketing Surveillance Trial
Baseline characteristics by cohort
| Measure |
Endeavor® Zotarolimus Eluting Coronary Stent System
n=1018 Participants
Endeavor® Zotarolimus Eluting Coronary Stent Implantation in a patient population requiring stent implantation.
|
|---|---|
|
Age, Continuous
|
63.16 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
274 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
744 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1018 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Of the one thousand and eighteen (1018) ITT patients, a total of nine hundred and forty seven (947) patients were included in the primary endpoint analysis. These patients had at least 1050 days of follow-up or had experienced stent thrombosis prior to 1080 days.
The primary endpoint rate of ARC-defined definite or probable stent thrombosis at 3 years.
Outcome measures
| Measure |
Endeavor® Zotarolimus Eluting Coronary Stent System
n=947 Participants
Intention to treat analyis has been used.
|
|---|---|
|
To Evaluate Overall Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System in a Patient Population Requiring Stent Implantation
|
1.2 percentage of participants
Interval 0.6 to 2.1
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Main secondary endpoint results for the ITT population are similar to the primary endpoint analysis, a total of nine hundred and forty seven (947) ITT patients had sufficient follow-up or an event to be included in the main secondary endpoint analyses.
Total death and and number of patients with all non-fatal myocardial infarction. Cardiac death and number of patients with all non-fatal myocardial infarction. Total death and number of patients with large non-fatal myocardial infarction. Cardiac death and number of patients with large non-fatal myocardial infarction.
Outcome measures
| Measure |
Endeavor® Zotarolimus Eluting Coronary Stent System
n=947 Participants
Intention to treat analyis has been used.
|
|---|---|
|
Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions.
the composite rate of death and/or MI
|
11.7 percentage of participants
Interval 9.7 to 13.9
|
|
Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions.
the composite rate of cardiac death and/or MI
|
8.2 percentage of participants
Interval 6.6 to 10.2
|
|
Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions.
composite rate of death and/or large MI
|
7.8 percentage of participants
Interval 6.2 to 9.7
|
|
Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions.
composite rate of cardiac death and/or large MI
|
4.2 percentage of participants
Interval 3.0 to 5.7
|
Adverse Events
Endeavor
Serious events: 415 serious events
Other events: 134 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Endeavor
n=1018 participants at risk
Medtronic Endeavor
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.98%
10/1018 • Number of events 12 • 12 months
|
|
Cardiac disorders
Acute Myocardial Infarction
|
2.9%
30/1018 • Number of events 36 • 12 months
|
|
Cardiac disorders
Angina Pectoris
|
4.8%
49/1018 • Number of events 55 • 12 months
|
|
Cardiac disorders
Angina Unstable
|
2.6%
26/1018 • Number of events 31 • 12 months
|
|
Cardiac disorders
Atrial Fibrillation
|
1.6%
16/1018 • Number of events 19 • 12 months
|
|
Cardiac disorders
Bradycardia
|
0.69%
7/1018 • Number of events 7 • 12 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.2%
12/1018 • Number of events 25 • 12 months
|
|
Cardiac disorders
Cardiac Tamponade
|
0.10%
1/1018 • Number of events 1 • 12 months
|
|
Cardiac disorders
Cardiogenic Shock
|
0.29%
3/1018 • Number of events 3 • 12 months
|
|
Cardiac disorders
Coronary Artery Disease
|
2.2%
22/1018 • Number of events 25 • 12 months
|
|
Cardiac disorders
Coronary Artery Dissection
|
2.8%
28/1018 • Number of events 29 • 12 months
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.20%
2/1018 • Number of events 2 • 12 months
|
|
Cardiac disorders
Coronary Artery Restenosis
|
0.49%
5/1018 • Number of events 5 • 12 months
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.49%
5/1018 • Number of events 5 • 12 months
|
|
Cardiac disorders
In-Stent Coronary Artery Restenosis
|
1.7%
17/1018 • Number of events 18 • 12 months
|
|
Cardiac disorders
Myocardial Infarction
|
1.7%
17/1018 • Number of events 17 • 12 months
|
|
Cardiac disorders
Pericarditis
|
0.10%
1/1018 • Number of events 1 • 12 months
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.10%
1/1018 • Number of events 1 • 12 months
|
|
Cardiac disorders
Tachycardia
|
0.20%
2/1018 • Number of events 2 • 12 months
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.20%
2/1018 • Number of events 2 • 12 months
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.39%
4/1018 • Number of events 4 • 12 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.29%
3/1018 • Number of events 3 • 12 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.4%
14/1018 • Number of events 15 • 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.49%
5/1018 • Number of events 5 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
2.4%
24/1018 • Number of events 28 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal Ulcer
|
0.10%
1/1018 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
0.20%
2/1018 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
0.20%
2/1018 • Number of events 2 • 12 months
|
|
General disorders
Chest Discomfort
|
0.88%
9/1018 • Number of events 9 • 12 months
|
|
General disorders
Chest Pain
|
6.8%
69/1018 • Number of events 93 • 12 months
|
|
General disorders
Death
|
0.59%
6/1018 • Number of events 6 • 12 months
|
|
General disorders
Fatigue
|
0.10%
1/1018 • Number of events 1 • 12 months
|
|
General disorders
Hernia
|
0.29%
3/1018 • Number of events 3 • 12 months
|
|
General disorders
Non-Cardiac Chest Pain
|
1.2%
12/1018 • Number of events 13 • 12 months
|
|
General disorders
Oedema Peripheral
|
0.20%
2/1018 • Number of events 2 • 12 months
|
|
General disorders
Pyrexia
|
0.10%
1/1018 • Number of events 1 • 12 months
|
|
General disorders
Unevaluable Event
|
14.8%
151/1018 • Number of events 237 • 12 months
|
|
General disorders
Vessel Puncture Site Haematoma
|
0.10%
1/1018 • Number of events 1 • 12 months
|
|
Immune system disorders
Hypersensitivity
|
0.29%
3/1018 • Number of events 3 • 12 months
|
|
Infections and infestations
Bronchitis
|
0.88%
9/1018 • Number of events 10 • 12 months
|
|
Infections and infestations
Diverticulitis
|
0.20%
2/1018 • Number of events 3 • 12 months
|
|
Infections and infestations
Infection
|
0.39%
4/1018 • Number of events 4 • 12 months
|
|
Infections and infestations
Pneumonia
|
1.7%
17/1018 • Number of events 20 • 12 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.49%
5/1018 • Number of events 8 • 12 months
|
|
Injury, poisoning and procedural complications
Stent Occlusion
|
0.20%
2/1018 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Thrombosis In Device
|
0.88%
9/1018 • Number of events 9 • 12 months
|
|
Investigations
Cardiac Enzymes Increased
|
0.88%
9/1018 • Number of events 9 • 12 months
|
|
Investigations
Electrocardiogram ST Segment Elevation
|
0.10%
1/1018 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.10%
1/1018 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.10%
1/1018 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.10%
1/1018 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.20%
2/1018 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.10%
1/1018 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.10%
1/1018 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.88%
9/1018 • Number of events 9 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.69%
7/1018 • Number of events 8 • 12 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
2.2%
22/1018 • Number of events 23 • 12 months
|
|
Nervous system disorders
Dizziness
|
0.20%
2/1018 • Number of events 2 • 12 months
|
|
Nervous system disorders
Presyncope
|
0.20%
2/1018 • Number of events 2 • 12 months
|
|
Nervous system disorders
Syncope
|
1.1%
11/1018 • Number of events 12 • 12 months
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.49%
5/1018 • Number of events 5 • 12 months
|
|
Psychiatric disorders
Depression
|
0.20%
2/1018 • Number of events 2 • 12 months
|
|
Renal and urinary disorders
Haematuria
|
0.59%
6/1018 • Number of events 8 • 12 months
|
|
Renal and urinary disorders
Renal Failure
|
1.1%
11/1018 • Number of events 11 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.59%
6/1018 • Number of events 6 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.10%
1/1018 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
21/1018 • Number of events 23 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.29%
3/1018 • Number of events 3 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.20%
2/1018 • Number of events 2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.10%
1/1018 • Number of events 1 • 12 months
|
|
Vascular disorders
Arterial Occlusive Disease
|
0.10%
1/1018 • Number of events 1 • 12 months
|
|
Vascular disorders
Arteriovenous Fistula
|
0.10%
1/1018 • Number of events 1 • 12 months
|
|
Vascular disorders
Haematoma
|
0.20%
2/1018 • Number of events 2 • 12 months
|
|
Vascular disorders
Haemorrhage
|
0.69%
7/1018 • Number of events 8 • 12 months
|
|
Vascular disorders
Hypertension
|
0.49%
5/1018 • Number of events 6 • 12 months
|
|
Vascular disorders
Hypotension
|
0.49%
5/1018 • Number of events 6 • 12 months
|
|
Vascular disorders
Peripheral Ischaemia
|
0.20%
2/1018 • Number of events 2 • 12 months
|
|
Vascular disorders
Vascular Pseudoaneurysm
|
0.39%
4/1018 • Number of events 4 • 12 months
|
Other adverse events
| Measure |
Endeavor
n=1018 participants at risk
Medtronic Endeavor
|
|---|---|
|
General disorders
Unevaluable Event
|
13.2%
134/1018 • Number of events 190 • 12 months
|
Additional Information
Lisa Bousquette, Director Clinical Research Coronary and Renal Denervation
Medtronic Cardiovascular
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee For any publication or presentation of the Protected Materials or any portion thereof, a maunscript of the paper, abstract or any materials will be provided by Consultant to Sponsor for its approval at least sixty (60days) for manuscripts and thirty (30) days for presentations prior to outside submission. Medtronic shall have the right to request reasonable modifications of any manuscript or other materials to be published or presented.
- Publication restrictions are in place
Restriction type: OTHER