Trial Outcomes & Findings for An Evaluation of the Commercially Available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System (NCT NCT01638507)
NCT ID: NCT01638507
Last Updated: 2019-04-03
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
230 participants
Primary outcome timeframe
12 months
Results posted on
2019-04-03
Participant Flow
230 PEG subjects were enrolled from 29 study sites in the United States. The first subject was enrolled on July 23, 2012 and the last subject was enrolled on May 31, 2013.
Participant milestones
| Measure |
Primary Enrollment Group (PEG)
Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
|
|---|---|
|
Overall Study
STARTED
|
230
|
|
Overall Study
COMPLETED
|
224
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Evaluation of the Commercially Available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System
Baseline characteristics by cohort
| Measure |
Primary Enrollment Group (PEG)
n=230 Participants
Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
|
|---|---|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
160 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The primary analysis set was the Intent-To-Treat (ITT) population, defined as all patients who signed the written informed consent and were enrolled in the study.
Outcome measures
| Measure |
Primary Enrollment Group (PEG)
n=220 Participants
Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents of less than or equal to 30 mm in length.
|
|---|---|
|
Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)
|
3.6 percentage of participants
Interval 1.6 to 7.0
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Primary Enrollment Group (PEG)
n=220 Participants
Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents of less than or equal to 30 mm in length.
|
|---|---|
|
Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI
|
15.0 percentage of composite
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Primary Enrollment Group (PEG)
n=220 Participants
Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents of less than or equal to 30 mm in length.
|
|---|---|
|
Clinical Endpoint: Death
|
1.8 percentage of death
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Primary Enrollment Group (PEG)
n=212 Participants
Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents of less than or equal to 30 mm in length.
|
|---|---|
|
Dual Antiplatelet Therapy (DAPT) Compliance
|
89.2 percentage of compliance
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Primary Enrollment Group (PEG)
n=220 Participants
Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents of less than or equal to 30 mm in length.
|
|---|---|
|
Clinical Endpoint: TLR
|
2.3 percentage of TLR
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Primary Enrollment Group (PEG)
n=220 Participants
Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents of less than or equal to 30 mm in length.
|
|---|---|
|
Clinical Endpoint: TVR
|
4.5 percentage of TVR
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Primary Enrollment Group (PEG)
n=220 Participants
Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents of less than or equal to 30 mm in length.
|
|---|---|
|
Clinical Endpoint: MI
|
2.7 percentage of MIs
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Primary Enrollment Group (PEG)
n=220 Participants
Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents of less than or equal to 30 mm in length.
|
|---|---|
|
Clinical Endpoint: ST
|
0.9 percentage of ST
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Primary Enrollment Group (PEG)
n=220 Participants
Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents of less than or equal to 30 mm in length.
|
|---|---|
|
Clinical Endpoint: Stroke
|
0.5 percentage of strokes
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Primary Enrollment Group (PEG)
n=220 Participants
Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents of less than or equal to 30 mm in length.
|
|---|---|
|
Clinical Endpoint: Bleeding Complications in General
|
11.4 percentage of bleeding complications
|
Adverse Events
Primary Enrollment Group (PEG)
Serious events: 88 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Primary Enrollment Group (PEG)
n=230 participants at risk
Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.87%
2/230 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.43%
1/230 • Number of events 1
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.43%
1/230 • Number of events 1
|
|
Cardiac disorders
Acute Myocardial Infarction
|
1.3%
3/230 • Number of events 3
|
|
Cardiac disorders
Angina Pectoris
|
3.0%
7/230 • Number of events 8
|
|
Cardiac disorders
Angina Unstable
|
1.7%
4/230 • Number of events 4
|
|
Cardiac disorders
Arteriospasm Coronary
|
0.43%
1/230 • Number of events 1
|
|
Cardiac disorders
Atrial Fibrillation
|
1.3%
3/230 • Number of events 3
|
|
Cardiac disorders
Cardiac Arrest
|
0.43%
1/230 • Number of events 1
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.43%
1/230 • Number of events 1
|
|
Cardiac disorders
Coronary Artery Disease
|
3.0%
7/230 • Number of events 7
|
|
Cardiac disorders
Coronary Artery Dissection
|
3.0%
7/230 • Number of events 7
|
|
Cardiac disorders
In-Stent Coronary Artery Restenosis
|
0.43%
1/230 • Number of events 1
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
0.43%
1/230 • Number of events 1
|
|
Cardiac disorders
Myocardial Infarction
|
2.2%
5/230 • Number of events 5
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.87%
2/230 • Number of events 2
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.43%
1/230 • Number of events 1
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.43%
1/230 • Number of events 1
|
|
Eye disorders
Deformity Of Orbit
|
0.43%
1/230 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.43%
1/230 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.43%
1/230 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal Mucosal Disorder
|
0.43%
1/230 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal Obstruction
|
0.43%
1/230 • Number of events 1
|
|
Gastrointestinal disorders
Melaena
|
0.43%
1/230 • Number of events 1
|
|
Gastrointestinal disorders
Mesenteric Artery Stenosis
|
0.43%
1/230 • Number of events 1
|
|
General disorders
Asthenia
|
0.43%
1/230 • Number of events 1
|
|
General disorders
Chest Discomfort
|
0.43%
1/230 • Number of events 1
|
|
General disorders
Chest Pain
|
7.4%
17/230 • Number of events 21
|
|
General disorders
Death
|
0.43%
1/230 • Number of events 1
|
|
General disorders
Drowning
|
0.43%
1/230 • Number of events 1
|
|
General disorders
Implant Site Haematoma
|
0.43%
1/230 • Number of events 1
|
|
General disorders
Non-Cardiac Chest Pain
|
1.7%
4/230 • Number of events 6
|
|
General disorders
Oedema Peripheral
|
0.43%
1/230 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.87%
2/230 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
0.43%
1/230 • Number of events 1
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.43%
1/230 • Number of events 1
|
|
Infections and infestations
Herpes Zoster
|
0.43%
1/230 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.7%
4/230 • Number of events 4
|
|
Infections and infestations
Sinusitis
|
0.43%
1/230 • Number of events 1
|
|
Infections and infestations
Urosepsis
|
0.43%
1/230 • Number of events 1
|
|
Injury, poisoning and procedural complications
In-Stent Arterial Restenosis
|
0.87%
2/230 • Number of events 2
|
|
Injury, poisoning and procedural complications
Thrombosis In Device
|
0.43%
1/230 • Number of events 1
|
|
Investigations
Cardiac Enzymes Increased
|
0.87%
2/230 • Number of events 2
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.43%
1/230 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle Haemorrhage
|
0.43%
1/230 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.43%
1/230 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.43%
1/230 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.43%
1/230 • Number of events 1
|
|
Nervous system disorders
Presyncope
|
0.43%
1/230 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.43%
1/230 • Number of events 1
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.43%
1/230 • Number of events 1
|
|
Psychiatric disorders
Factitious Disorder
|
0.43%
1/230 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.43%
1/230 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.43%
1/230 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure
|
0.43%
1/230 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.43%
1/230 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.43%
1/230 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.43%
1/230 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
3/230 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.43%
1/230 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Disorder
|
0.43%
1/230 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.43%
1/230 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.43%
1/230 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.43%
1/230 • Number of events 1
|
|
Surgical and medical procedures
Therapeutic Embolisation
|
0.43%
1/230 • Number of events 1
|
|
Vascular disorders
Aortic Aneurysm
|
0.43%
1/230 • Number of events 1
|
|
Vascular disorders
Arterial Haemorrhage
|
0.43%
1/230 • Number of events 1
|
|
Vascular disorders
Arteriosclerosis
|
0.43%
1/230 • Number of events 1
|
|
Vascular disorders
Artery Dissection
|
0.43%
1/230 • Number of events 1
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.43%
1/230 • Number of events 1
|
|
Vascular disorders
Femoral Artery Occlusion
|
0.43%
1/230 • Number of events 1
|
|
Vascular disorders
Haematoma
|
0.43%
1/230 • Number of events 1
|
|
Vascular disorders
Intermittent Claudication
|
0.43%
1/230 • Number of events 1
|
|
Vascular disorders
Orthostatic Hypotension
|
0.43%
1/230 • Number of events 1
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.43%
1/230 • Number of events 1
|
|
Vascular disorders
Shock Haemorrhagic
|
0.43%
1/230 • Number of events 1
|
|
Vascular disorders
Vascular Occlusion
|
1.3%
3/230 • Number of events 3
|
|
Vascular disorders
Vascular Pseudoaneurysm
|
0.43%
1/230 • Number of events 1
|
Other adverse events
| Measure |
Primary Enrollment Group (PEG)
n=230 participants at risk
Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
|
|---|---|
|
Cardiac disorders
Angina Pectoris
|
5.7%
13/230 • Number of events 15
|
|
General disorders
Chest Pain
|
10.4%
24/230 • Number of events 26
|
|
Investigations
Cardiac Enzymes Increased
|
6.1%
14/230 • Number of events 14
|
Additional Information
Lisa Bousquette, Clinical Research Director
Medtronic, Coronary Clinical Affairs
Phone: (707) 591-2967
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 manuscript 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