To assess the safety and effectiveness of enVast coronary thrombectomy system thrombectomy as an adjunctive measure to conventional intervention as compared to conventional intervention in ST-segment elevation myocardial infarction (STEMI) patients…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
the size of the infarct as assessed by measurement of CK-MB. Blood samples will
be obtained at admission and repeatedly over Days 1, 2, and 3. The area under
the curve (AUC) for creatine kinase MB (CK-MB, expressed in ng/mL), will be
measured in each subject.
Secondary outcome
Other clinically important endpoints include, but are not limited to:
• Infarct size, salvage index, microvascular obstruction, LV volumes and
intramyocardial hemorrhage as measured by MRI.
• AUC for CK and hsTroponin T.
• The cumulative ST-segment deviation and residual ST-segment elevation
resolution (calculated as the sum in mm of any ST-elevation and
depression) to be measured immediately after the end of intervention and 90
minutes thereafter.
• TIMI flow, Corrected TIMI frame count and myocardial blush grade at the end
of the procedure
• Left ventricular ejection fraction (LVEF), and LV volumes will be collected
at day 3 and 5±2 months with MRI and at discharge and 12 months with
transthoracic echocardiography, and they will be assessed by the core lab
• Kinetics of B-type natriuretic peptide during index hospitalization
• Histopathological evaluation of the retrived thrombotic material
The primary safety endpoint is MACE at Day 3 defined as cardiovascular death,
nonfatal myocardial infarction, or nonfatal stroke.
Serious adverse events (SAEs) throughout the 1-year follow-up will be described
according to severity and to their relationship with the study device and
procedure. Descriptive statistics (N, mean, median, SD, minimum and maximum
values, where applicable) will be used to characterize safety parameters.
Other important safety endpoints will include:
• The composite of cardiovascular death, MI, and any cerebrovascular accident,
including transient ischemic attack or stroke
• Death from cardiovascular causes
• Definite or probable stent thrombosis
• New onset cardiogenic shock requiring inotropes or mechanical assist device
• Myocardial infarction
• Stroke or transient ischemic attack
• Bleeding events (access site or non-access site related) according to the
BARC classification.
• Rehospitalization for heart failure, resuscitated cardiac arrest or
implantable cardioverter-defibrillator (ICD) implantation at follow-up.
• Bailout use of parenteral anti-platelet agents (GPI or cangrelor) defined as
any use during or after the procedure in patients in whom no intention to use a
parenteral anti-platelet agent was declared at the time of randomization.
• Any urgent or non-urgent target vessel revascularization
Background summary
In this study, we look at the safety and effectiveness of the medical device
called enVast*.
This is a stent that can expand in the blood vessel of the heart, but can also
be removed again (stent retriever).
This is used to remove blood clots from the heart vessels.
In some people with a heart attack, especially acute ST-segment elevation
myocardial infarction (STEMI), the clogged blood vessel also contains a blood
clot.
Usually an attempt is made to partially resolve this by sucking out the clot,
with medication or to do nothing.
Another option is to use a stent retriever, which the cardiologist can use to
remove the clot.
The doctor then tries to pull the clot out of the blood vessel and restore
blood flow.
The study was designed to compare enVast* with standard treatments.
Study objective
To assess the safety and effectiveness of enVast coronary thrombectomy system
thrombectomy as an adjunctive measure to conventional intervention as compared
to conventional intervention in ST-segment elevation myocardial infarction
(STEMI) patients with large thrombus burden undergoing primary percutaneous
coronary intervention.
Study design
A prospective, randomized, study with one-year follow-up, designed to assess
the safety and effectiveness of thrombus removal with the enVast coronary
thrombectomy systems in STEMI patients.
Intervention
Subjects will be treated according to the treatment arm to which they have been
assigned (either the thrombectomy arm of the enVast Coronary Thrombectomy
System or the conventional treatment arm).
In the conventional treatment arm, treatment strategies may include balloon
angioplasty, manual aspiration thrombectomy, and/or coronary stenting. The use
of intravascular imaging modalities, including intravascular ultrasonography or
optical coherence tomography, is permissible at any stage of the intervention
according to institutional practice.
In the thrombectomy arm of the enVast Coronary Thrombectomy System, up to 3
attempts are made to remove a thrombus with the enVast before proceeding to
treatment with conventional methods. The use of intravascular imaging
modalities, including intravascular ultrasonography or optical coherence
tomography, is permissible at any stage of the intervention according to
institutional practice.
Study burden and risks
The anticipated adverse events associated with the cardiac thrombectomy
procedure in this study include events reported in literature related to
removal of clots, events identified in the risk and hazard analyses, and events
associated with percutaneous interventions. All of these represent the risks
associated with participation in the trial.
Potential device malfunctions and potential user errors have been identified in
the Hazard Analysis and Failure Modes and Effects Analysis exercises conducted
in accordance with ISO 14971. These are technical complications that may occur
with the devices. Mitigating steps to address each of the potential device
malfunctions and potential user errors have been implemented to reduce the
risks as low as possible. No residual risks remain that are higher than the
risks associated with the use of currently available conventional cardiac
mapping and ablation tools.
Overall potential patient benefits include revascularization of occluded target
vessel and preservation of function post-STEMI. Potential risks include adverse
events and potential device malfunctions. Potential user errors are similar to
those associated with other commercially available thrombectomy devices.
Based on a review of the potential benefits and the clinical need along with
the residual risks identified through the completion of risk management
activities to date, the overall residual risk is considered appropriate for the
clinical benefits.
Test results from routinely performed standard of care assessments in STEMI
management may be used throughout the study duration of 12 months per subject
Andreasommegang 61
Sittard 6133BW
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Andreasommegang 61
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Listed location countries
Age
Inclusion criteria
1. Age >=18 years
2. Chest pain for >20 min with an electrocardiographic ST-segment elevation >=1
mm in two or more contiguous electrocardiogram (ECG) leads or an infero-lateral
myocardial infarction (MI) with ST segment depression of >=1 mm in >=2 of leads
V1-3 with a positive terminal T wave.
3. TIMI Thrombus Grade >= 3 in the infarct related artery. In cases where TIMI
Thrombus Grade is equal to 5 (i.e. TIMI 0 flow in the infarcted artery), TIMI
Thrombus Grade of at least 3 has to be re-confirmed with AWI. Patients showing
TIMI Thrombus Grade of less than 3 upon AWI are no longer eligible for
randomization.
4. Start of intervention within 8 h of symptom onset
5. Deferred consent after intervention signed by capable subject, signed by
legal representative in case of incapable subject (subject remains included if
deferred post-interventional consent was not signed before death).
Exclusion criteria
1. Unconscious patients
2. Infarct related artery diameter, at visual assessment, smaller than 2.5 mm
3. Presence of severely calcified plaque(s) proximal to or at the site of the
culprit lesion(s)
4. Presence of extreme vessel tortuosity proximal to or at the site of the
culprit lesion(s)
5. Women of childbearing potential (e.g. below 55 years of age, who have not
undergone tubal ligation, ovariectomy or hysterectomy)
6. Stent thrombosis as culprit lesion
7. Previous myocardial infarction in the same territory (i.e. same target
vessel).
8. Participation in another interventional clinical trial
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 | NCT04969471 |
| CCMO | NL84467.100.23 |