Coronary Artery Disease
Conditions
Keywords
TARGET LESION REVASCULARIZATION (TLR), TARGET VESSEL REVASCULARIZATION (TVR), Coronary Artery Disease, MYOCARDIAL INFARCTION (MI), PERCUTANEOUS CORONARY INTERVENTION (PCI), STENT THROMBOSIS, TARGET LESION FAILURE (TLF)
Brief summary
The purpose of this post approval study is to conduct a prospective, multicenter evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System.
Detailed description
The purpose and objective is to assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter(RD) of 2.25mm to 4.2mm in two groups of patients, specifically those patients receiving stents less than or equal to 30mm in length.
Interventions
DEVICEResolute Integrity Stent
Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System
Sponsors
Medtronic Vascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General and Angiographic Inclusion Criteria highlights: * Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery * Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study * Informed consent * Patient agrees to comply with specified follow-up evaluations * Single target lesion or two target lesions located in separate coronary arteries * De novo lesion(s) in native coronary artery(ies) * Target lesion(s) ≤ 27 mm in length * Target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm General and Angiographic
Exclusion criteria
highlights: * Within 7 days of index procedure platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³; White Blood Cell (WBC) count \<3,000 cells/mm³; serum creatinine level \>2.5 mg/dl * Acute MI within 72 hrs of the intended trial procedure (QWMI or any elevation of Creatine Kinase-MB (CK-MB) \> lab upper limit of normal) * Previous PCI of target vessel(s) within 9 months prior to the procedure * Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure * History of stroke or Transient Ischemic Attack (TIA) within prior 6 months * Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints * Inability to comply with required trial antiplatelet regimen * Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent * Target vessel(s) has/have other lesions w/ \> 40% diameter stenosis * Unprotected left main coronary artery disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Endpoint: Death | 12 months |
| Dual Antiplatelet Therapy (DAPT) Compliance | 12 months |
| Clinical Endpoint: TLR | 12 months |
| Clinical Endpoint: TVR | 12 months |
| Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI | 12 months |
| Clinical Endpoint: ST | 12 months |
| Clinical Endpoint: Stroke | 12 months |
| Clinical Endpoint: Bleeding Complications in General | 12 months |
| Clinical Endpoint: MI | 12 months |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Primary Enrollment Group (PEG) 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. | 230 |
| Total | 230 |
Baseline characteristics
| Characteristic | Primary Enrollment Group (PEG) |
|---|---|
| Age, Continuous | 64.4 years STANDARD_DEVIATION 10.5 |
| Sex: Female, Male Female | 70 Participants |
| Sex: Female, Male Male | 160 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 51 / 230 |
| serious Total, serious adverse events | 88 / 230 |
Outcome results
Primary
Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Enrollment Group (PEG) | Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI) | 3.6 percentage of participants |
Secondary
Clinical Endpoint: Bleeding Complications in General
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Enrollment Group (PEG) | Clinical Endpoint: Bleeding Complications in General | 11.4 percentage of bleeding complications |
Secondary
Clinical Endpoint: Death
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Enrollment Group (PEG) | Clinical Endpoint: Death | 1.8 percentage of death |
Secondary
Clinical Endpoint: MI
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Enrollment Group (PEG) | Clinical Endpoint: MI | 2.7 percentage of MIs |
Secondary
Clinical Endpoint: ST
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Enrollment Group (PEG) | Clinical Endpoint: ST | 0.9 percentage of ST |
Secondary
Clinical Endpoint: Stroke
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Enrollment Group (PEG) | Clinical Endpoint: Stroke | 0.5 percentage of strokes |
Secondary
Clinical Endpoint: TLR
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Enrollment Group (PEG) | Clinical Endpoint: TLR | 2.3 percentage of TLR |
Secondary
Clinical Endpoint: TVR
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Enrollment Group (PEG) | Clinical Endpoint: TVR | 4.5 percentage of TVR |
Secondary
Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Enrollment Group (PEG) | 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
Dual Antiplatelet Therapy (DAPT) Compliance
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Enrollment Group (PEG) | Dual Antiplatelet Therapy (DAPT) Compliance | 89.2 percentage of compliance |