Coronary Artery Disease, Myocardial Ischemia
Conditions
Keywords
restenosis, Coronary Disease, Coronary Arteriosclerosis, Arterial Occlusive Diseases
Brief summary
To assess the feasibility and safety of the Medtronic Bifurcation Stent System for the treatment of single de novo bifurcation lesions in native coronary arteries with reference vessel diameters (RVD) for the proximal main vessel of 3.8 - 4.3 mm, distal main branch of 3.0 - 3.5 mm, and side branch RVD up to 2.5 mm.
Interventions
DEVICEMedtronic Bifurcation Stent System
Percutaneous Coronary Stenting
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 Inclusion Criteria * Candidate for percutaneous coronary intervention & emergent coronary artery bypass graft surgery * Clinical evidence of ischemic heart disease or a positive functional study * Female patients of childbearing potential has negative pregnancy test within 7 days before trial procedure * Patient or patient's legal representative provided written informed consent * Patient agrees to comply with follow-up evaluations Angiographic Inclusion Criteria * Target lesion ia a single de novo bifurcation lesion involving a native coronary artery with reference vessel diameter for the proximal main of 3.8 - 4.3 mm, distal main of 3.0 - 3.5 mm, & side branch RVD up to 2.5 mm * Acceptable target lesion lengths are any combination of: * \<16mm proximally from carina in proximal main vessel * \<16mm distally from the carina in distal main branch * \<12mm from carina in side branch * Target lesion in main vessel has stenosis of \> 50% and \<100% * Target vessel has (TIMI) flow \>2 General
Exclusion criteria
* Known hypersensitivity/contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, chromium, molybdenum, or sensitivity to contrast media, which can't be adequately pre-medicated * Platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³, or a white blood cell (WBC) count \<3,000 cells/mm³ within 7 days prior to index procedure * Serum creatinine level \>170 micromol/L within 7 days prior to index procedure * Evidence of acute MI within 72 hours of intended trial procedure (defined as: QWMI or NQWMI having CK enzymes \>2X laboratory upper limit of normal with presence of elevated CK-MB (any amount above laboratory upper limit of normal) * Previous stenting anywhere in target vessel * PCI of non-target vessel within 30 days prior to procedure that results in any MACE event. If non target vessel stent is implanted within 72 hours prior to index procedure, 2 post procedural serial CK or CK-MB measurements must be below investigational site's upper limit of normal. * PCI of non-target vessel within 24 hours prior to procedure * Planned PCI of any vessel within 30 days post-procedure * Planned PCI of the target vessel within 6 months post-procedure * During index procedure, target lesion requires treatment with device other than PTCA or cutting balloon prior to stent placement * Documented left ventricular ejection fraction (LVEF) \<30% at most recent evaluation. * History of stroke or transient ischemic attack (TIA) within prior 6 months * Active peptic ulcer or upper gastrointestinal (GI) bleeding within prior 6 months * History of bleeding diathesis or coagulopathy or will refuse blood transfusions * Concurrent medical condition with life expectancy \< 12 months * Currently participating in investigational drug or device trial that's not completed the primary endpoint or that clinically interferes with current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Target Vessel Failure (TVF) at 30 Days Post Procedure. | 30 days | TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Success | During index procedure | Device success is reported as Historical-standard definition: attainment of \<50% residual stenosis of all target lesion/s using only the assigned device and any adjunct stents as specified in the Investigational Plan. |
| Number of Participants With Target Vessel Failure (TVF) at 6 Months | 6 month | TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization. |
| Number of Participants With Target Vessel Failure at 9 Months. | 9 month | TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization. |
| Number of Participant With Target Vessel Failure at 12 Months | 12 month | TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization. |
Countries
New Zealand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Medtronic Bifurcation Stent System Single arm, All patients single de novo bifurcation lesions; 7 run-in subjects not included in analysis | 53 |
| Total | 53 |
Baseline characteristics
| Characteristic | Medtronic Bifurcation Stent System |
|---|---|
| Age, Continuous | 60.4 years STANDARD_DEVIATION 11.74 |
| Region of Enrollment Australia | 39 participants |
| Region of Enrollment New Zealand | 14 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 46 / 60 |
| serious Total, serious adverse events | 23 / 60 |
Outcome results
Primary
Number of Participants With Target Vessel Failure (TVF) at 30 Days Post Procedure.
TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Receiving Bifurcation Stents | Number of Participants With Target Vessel Failure (TVF) at 30 Days Post Procedure. | 2 Participants |
Secondary
Device Success
Device success is reported as Historical-standard definition: attainment of \<50% residual stenosis of all target lesion/s using only the assigned device and any adjunct stents as specified in the Investigational Plan.
Time frame: During index procedure
Population: ITT included all subjects after a run-in subject at each site.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Receiving Bifurcation Stents | Device Success | 46 participants |
Secondary
Number of Participants With Target Vessel Failure at 9 Months.
TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.
Time frame: 9 month
Population: Includes all subjects receiving bifurcation stents and having evaluable data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Receiving Bifurcation Stents | Number of Participants With Target Vessel Failure at 9 Months. | 6 participants |
Secondary
Number of Participants With Target Vessel Failure (TVF) at 6 Months
TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.
Time frame: 6 month
Population: Includes all patients receiving bifurcation stent and having evaluable data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Receiving Bifurcation Stents | Number of Participants With Target Vessel Failure (TVF) at 6 Months | 4 participants |
Secondary
Number of Participant With Target Vessel Failure at 12 Months
TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.
Time frame: 12 month
Population: Includes all subjects receiving bifurcation stents and having evaluable data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Receiving Bifurcation Stents | Number of Participant With Target Vessel Failure at 12 Months | 6 participants |