The objective of this study is to evaluate the safety and efficacy of the MGuard* Prime stent in the treatment of de novo stenotic lesions in coronary arteries in patients undergoing primary PCI due to acute STEMI as compared with BMS or DES in the…
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficacy endpoint is the rate of complete ST-segment resolution
defined as percentage of subjects with >70% resolution of the sum of ST
elevations in all affected ECG leads within 60-90 minutes of completion of the
stent procedure, powered to demonstrate superiority of the MGuard* Prime Stent
compared to the control arm.
The primary safety endpoint is a composite of all-cause death or recurrent
target vessel myocardial infarction (TV re-MI) at 365 days post-procedure,
powered to demonstrate non-inferiority of the MGuard* Prime Stent compared to
the control arm.
Secondary outcome
1. Infarct size assessed by cardiac magnetic resonance imaging (MRI) (from the
first 356 eligible, consecutively enrolled subjects with anterior MI and
proximal or mid LAD infarct vessel, at MRI-designated centers), with follow-up
MRI conducted at 5 ± 2 days(range 3-7 days), powered for superiority
2. In-stent late lumen loss (LLL) (from the first 200 eligible, consecutively
enrolled subjects at angiographic and IVUS follow-up designated centers
stratified to intent to treat with BMS, and treated with the MGuardTM Prime or
with BMS (if randomized to the control arm), as measured by quantitative
coronary angiography [QCA] at 13 months), powered for non-inferiority
3. Procedural assessment of the coronary flow:
a. TIMI flow grade
b. Corrected TIMI frame count
c. Myocardial blush grade
d. Intra-procedural thrombotic events (IPTE)
4. Major Adverse Cardiac Events (MACE): defined as the composite of cardiac
death, re-MI, or clinically-driven target lesion revascularization (TLR) at 30
days, 6, and 12 months
5. Composite endpoint of all-cause death or TV re-MI at 30 days and 6 months
6. Target vessel failure (TVF), defined as the composite of all-cause death, TV
re-MI, or clinically-driven target vessel revascularization (TVR) at 30 days, 6
months and 12 months
7. Target lesion failure (TLF) defined as the composite of cardiac death,
target vessel re-MI, or clinically-driven TLR at 30 days, 6, and 12 months
8. Cardiovascular Death or TV-re-MI at 30 days, 6, and 12 months
9. Rates for each component of the MACE, TVF and TLF composite endpoints
reported at 30 days, 6, and 12 months
10. Acute Success Rates:
a. Device Success: Attainment of < 30% final residual stenosis of the target
lesion using only the assigned stent.
b. Lesion Success: Attainment of < 30% final residual stenosis of the target
lesion using any percutaneous method.
c. Procedure Success: Attainment of < 30% final residual stenosis of the target
lesion using only the assigned stent, TIMI flow
InspireMD Acute MI Randomized Controlled Trial
InspireMD Protocol HCRI CONFIDENTIAL Page 9 of 103 pages
April 21, 2013, Version 6.0
SECONDARY ENDPOINTS (CONT)
grade 3 and no in-hospital MACE.
11. Bleeding or vascular complications at discharge
12. Stent thrombosis at 30 days, 6 and 12 months (ARC definition)
a. Definite stent thrombosis
b. Probable stent thrombosis
c. Definite or probable stent thrombosis
13. Angiographic Endpoints at 13-months by QCA, in patients enrolled in the
angiographic follow-up substudy
a. In-stent and in-segment (within the 5 mm margins proximal and distal to
stent)
- Percent diameter stenosis (%DS)
- Late loss
- Binary restenosis (stenosis of > 50% of the reference vessel diameter)
- Minimum lumen diameter (MLD)
14. IVUS Endpoints at 13-months, in patients enrolled in the angiographic and
IVUS follow-up substudy
a. In-stent percent volume obstruction (%VO)
b. Neointimal hyperplasia (NIH) volume
c. Incomplete stent apposition
15. MRI Endpoints at 5-days, in patients enrolled in the cardiac MRI follow-up
substudy
a. Microvascular obstruction (MVO)
b. LV ejection fraction (LVEF)
c. Left ventricular (LV) end-systolic and end-diastolic volumes
d. Area at risk
Background summary
A heart attack is also known as a "myocardial infarction" (MI). A heart attack
occurs when there is a blockage of blood flow in one or more of the coronary
blood vessels (arteries) that supply blood to the heart muscle. A heart attack
can occur when coronary arteries become blocked due to coronary artery disease
(CAD). This blockage is due to a build-up of fat-like deposits (plaque) on the
artery walls. This process is called atherosclerosis.
PCI is a treatment procedure that enlarges narrowed coronary arteries without
performing surgery.
*Balloon catheter angioplasty: A small balloon is placed in the narrowed area
of the artery and inflated with liquid. This pushes the plaque (blockage) to
the sides of the artery where it remains. This technique restores the opening
of the artery. The cardiologist removes the balloon at the end of the
procedure. This procedure is often used in combination with a stent.
*Stent: The cardiologist places a small, hollow metal (mesh) tube called a
*stent* in the artery to keep it open following a balloon angioplasty. This
technique prevents constriction or closing of the artery during and after the
procedure.
During stent placement, distal embolization often occurs. Small thrombus
material will clod within the micovasculature and hamperes the restoration of
the coronary blood flow.
.
Study objective
The objective of this study is to evaluate the safety and efficacy of the
MGuard* Prime stent in the treatment of de novo stenotic lesions in coronary
arteries in patients undergoing primary PCI due to acute STEMI as compared with
BMS or DES in the control arm. The MGuard* Prime stent has a fiber mesh that
traps the thrombus material between the stent and the vessel wall, preventing
distal embolization,
Study design
Prospective , multicentre, randomised (1:1) clinical evaluation.
Total enrollment of 1114 subjects (557 in the MGuard* Prime System group and
557 in the control group), at up to 70 sites worldwide (a minimum of 40% US
sites will be included). A minimum of 40% of the total enrollment will be from
US sites. A maximum of 150 subjects will be enrolled at any one site.
Intervention
stenting with MGuard prime stent or a control DES or BMS
Study burden and risks
The subjects would also be subjected to most of the risks, even if they would
not participate in the trial.
Subjects undergo a repeat coronar angigraphy at 13 months with IVUS. A coronar
angigraphy has a know low risk this will take place in day treatment.
A small group of patients will have a MRI 3-7 days after the procedure; this
can be experienced as uncomfortable by the patient.
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New York NY
US
Listed location countries
Age
Inclusion criteria
General Inclusion Criteria
1. Subject is * 18 years of age.
2. Subject is experiencing clinical symptoms consistent with acute myocardial infarction (AMI) of >30 minutes and *12 hours in duration.
3. ST elevation *2 mm per lead in *2 contiguous leads is present in one ECG prior to consent.
4. Subject agrees to all required follow-up procedures and visits.
5. Subject provides written, informed consent.;Angiographic Inclusion Criteria
1. The target lesion is a de novo lesion in a native coronary artery.
2. Based on coronary anatomy, PCI is indicated for the culprit lesion with anticipated use of stenting.
3. The reference vessel diameter (RVD) of the infarct lesion is 2.75-4.0 mm by visual assessment, assessed either at baseline (if direct stenting is planned), or after pre-dilatation or thrombus aspiration (if direct stenting is not planned).
4. The entire lesion length requiring treatment is *24 mm (able to be covered by a single study stent), assessed either at baseline (if direct stenting is planned), or after pre-dilatation or thrombus aspiration (if direct stenting is not planned)
5. TIMI flow of 2/3 is present prior to randomization (in case of baseline TIMI flow 0/1, blood flow must be restored).
Exclusion criteria
General Exclusion Criteria
1. Left bundle branch block (LBBB), paced rhythm, or other ECG abnormality interfering with assessment of ST-segment.
2. Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
3. A previous coronary interventional procedure of any kind within 30 days prior to the procedure.
4. Female patients of childbearing potential.
5. Subject undergoing cardiopulmonary resuscitation (patients in whom cardiopulmonary resuscitation was successfully performed and in whom normal mental status was achieved, may be enrolled).
6. Cardiogenic shock (SBP <80 mmHg for >30 minutes, or requiring IV pressors or intra-aortic balloon bump (IABP) or other hemodynamic support device for hypotension).
7. The subject requires a staged procedure of the target vessel (including branches) within 12 months or of any non-target vessel within 7 days post-procedure.
8. The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to excimer laser, rotational atherectomy, etc.). Manual thrombus aspiration may be used per operator discretion, but rheolytic thrombectomy is only permitted for procedural complications after randomization.
9. Prior administration of thrombolytic therapy for the current admission
10. Co-morbid condition(s) that could limit the subject*s ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
11. Concurrent medical condition with a life expectancy of less than 12 months.
12. History of cerebrovascular accident or transient ischemic attack within the last 6 months, or any permanent neurologic deficit
13. Prior intracranial bleed at any time, or known intracranial pathology (e.g. tumor, arteriovenous malformation, or aneurysm).
14. Active or recent site of major bleeding within 6 months.
15. History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
16. Known hypersensitivity or contraindication to either i) aspirin, or heparin and bivalirudin; or ii) clopidogrel , ticlopidine, prasugrel and ticagrelor; or iii) cobalt or nickel; or iv) contrast media, which cannot be adequately pre-medicated (prior anaphylaxis, however, is an absolute contraindication to enrollment).
17. Known serum creatinine level >2.5 mg/dl, hemoglobin <10 g/dL or platelet count <150,000 for the present admission or within 7 days prior to index procedure, if available. NOTE: Baseline labs do not have to be available to consent patient. If laboratory results become available only after randomization, and do not meet inclusion and exclusion criteria, the patient will not be de-registered from the study.
18. Surgery planned or any other reason necessitating discontinuation of dual anti-platelet therapy (aspirin and an ADP antagonist) within 12 months
19. Aortic dissection or mechanical complication of STEMI (papillary muscle rupture, ventricular septal defect or free wall rupture with or without pseudoaneurysm) identified by echocardiography or other means;Angiographic Exclusion Criteria
1. Unprotected left main stenosis *50%.
2. Multi-vessel intervention required during the index procedure.
3. Excessive tortuosity, calcification or diffuse distal disease is present either proximal to, at or distal to the target lesion making it unlikely that the study stent is unable to reach or cross the target lesion.
4. A non-infarct lesion with stenosis *50% is present in the target vessel (including its branches)
5. Target lesion is a bifurcation with a side branch *2.0 mm in diameter.
6. Target lesion at the site of or within a vessel with a previously implanted stent
7. Target lesion is within a bypass graft conduit, or can only be reached by passing the study stent through a bypass graft conduit
8. In the Investigator*s opinion the lesion/vessel is unsuitable for treatment with the study stent for any reason.
9. The lesion requires use of atherectomy, thrombectomy (not including manual thrombus aspiration catheters), laser devices, or proximal or distal embolic protection devices prior to randomization.
10. Aortic dissection or mechanical complication of STEMI (papillary muscle rupture, ventricular septal defect or free wall rupture with or without pseudoaneurysm) identified by left ventriculography
Cardiac MRI Sub-study Exclusion Criteria (Only Applicable to Subjects Enrolled in the Cardiac MRI Sub-study)
1. Planned staged procedure prior to the MRI test.
2. A cardiac pacemaker or implantable defibrillator.
3. Non-MRI-compatible aneurysm clip.
4. Neural stimulator (e.g., TENS-Unit).
5. Any implanted or magnetically activated device (e.g., insulin pump).
6. Any type of non-MRI-compatible metallic ear implant.
7. Metal shavings in the orbits.
8. Any metallic foreign body, shrapnel, or bullet in a location which the physician feels would present a risk to the subject.
9. Any history indicating contraindication to MRI, including claustrophobia or allergy to gadolinium.
10. Inability to follow breathhold instructions or to maintain a breathhold for >15 seconds.
11. Irregular cardiac rhythm not expected to resolve after treatment of the acute cardiac condition (e.g., chronic atrial fibrillation).
12. Known hypersensitivity or contraindication to gadolinium contrast.
13. Impaired renal function (creatinine clearance <30 ml/min/1.73m2 [or <51.99 cc/min estimated with the Cockcroft-Gault formula]) or on dialysis.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01869738 |
| CCMO | NL44890.018.13 |