Primary Objective:Proof of concept study designed to document the safety and feasibility of adjuvant treatment with the PICSO Impulse system in patients with acute anterior ST-segment elevation myocardial infarction (STEMI) treated with primary PCI…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assessment of the feasibility of PICSO in STEMI patients defined as the
successful delivery of the PICSO Impulse catheter and successful administration
of PICSO treatment for 90 minutes
Secondary outcome
Secondary Endpoints:
1. ST-segment time curve area for the first 3 hours on 24 hour continuous
12-lead ECG Holter monitor recording.
2. Occurrence of complete resolution of ST-segment elevation 30, 60, 90 and 120
minutes after last contrast injection prior to PICSO placement procedure on 24
hour continuous 12-lead ECG Holter monitor recording.
3. Microvascular perfusion assessed by MRI between 2-5 days post-primary PCI
procedure and at 120±14 days follow-up.
4. Infarct size assessed by MRI between 2-5 days after primary PCI and at
120±14 days follow-up.
5. Left ventricular function assessed by echocardiography between 2-5 days
after primary PCI and at 120±14 days follow-up.
Safety Endpoints:
1. Major adverse cardiac events (MACE)
2. Major adverse cardiac and cerebrovascular events (MACCE)
3. Net adverse clinical events (MACE + Bleeding)
4. (Severe) Adverse Device Event ((S)ADE) rates
Exploratory MRI endpoints:
1. Microvascular obstruction (in grams and percentage of total left ventricular
mass and percentage of total infarct mass) assessed by MRI between 2-5 days
post-primary PCI procedure and at 120±14 days follow-up.
2. Left ventricular ejection fraction (%), left ventricular end-diastolic
volume (mL), and left ventricular end-systolic volume (mL) at 2-5 days and at
120±14 days.
3. Transmural extent of infarction (%).
Background summary
the presence of collateral flow in case of obstructive coronary artery disease
or acute myocardial infarction has beneficial effects on morbidity and
mortality. Pressure-controlled intermittent coronary sinus occlusion (PICSO)
carries a promise of improving myocardial flow, decreasing microvascular
obstruction and decreasing the rate of periprocedural and acute myocardial
infarction without the increased risk of bleeding such as is encountered with
GP2b3a inhibitors. We expect that PICSO is able to reduce infarct size in
patients with acute myocardial infarction and thereby may improve long term
outcome.
Study objective
Primary Objective:
Proof of concept study designed to document the safety and feasibility of
adjuvant treatment with the PICSO Impulse system in patients with acute
anterior ST-segment elevation myocardial infarction (STEMI) treated with
primary PCI.
Secondary objective:
To assess the utility of different outcome measures of myocardial function
following PICSO use in patients with acute anterior STEMI treated with primary
PCI
Study design
A prospective multi-center study in which patients with an acute, left anterior
descending artery (LAD) culprit ST-segment elevation myocardial infarction
(STEMI) receive primary PCI (angioplasty followed by stent placement) and
adjuvant 90 minutes PICSO treatment using the Miracor PICSO Impulse System
Intervention
All included patiénts will receive adjuvant PICSO treatment. This contains the
insertion of the PICSO Impulse catheter through a femoral vein puncture en the
administration of the PICSO treatment for 90 minutes.
Study burden and risks
Risk specifically introduced by the use of the PICSO Impulse system are
bleeding complications in the groin due to the venous puncture necessary for
introduction of the catheter as well as the presence of the catheter for
approximately 90 minutes.
Possible complications are pulmonary emboli, and injury or chronic occlusion
of the coronary sinus. These complications have, however, not been observed in
previous clinical trials, and these are therefore considered to be rare.
The burden for a single patient consists of the PICSO treatment for 90 minutes.
Apart from the treatment, patients are asked to return to the outpatient clinic
of the AMC three times, with an additional MRI-scan and echocardiography during
the 4-months follow up visit. A follow-up visit consists of history-taking,
routine laboratory testing, electrocardiography and a physical examination. The
follow-up visits last for approximately 30 minutes, the MRI-scan at four months
follow up 90 minutes, the echocardiography at four months follow up 15 minutes
. The total burden for the patient is 300 minutes during a 6 month period.
Gumpendorfer Strasse 139 (top 1.05)
A-1060 Vienna
AT
Gumpendorfer Strasse 139 (top 1.05)
A-1060 Vienna
AT
Listed location countries
Age
Inclusion criteria
1.First time anterior STEMI defined by the following:
a.Symptoms of myocardial ischemia > 30 minutes and < 12 hours.
b.ST-segment elevation > 1mm (> 0.1 mV) in two contiguous precordial leads in the anterior territory on a 12-lead ECG.
2.Uncomplicated PCI of a LAD culprit lesion
(defined as angioplasty followed by stent placement or direct stenting without the occurrence of an adverse event(s) that would preclude further study participation, such as major bleeding, perforation, hypotension, pulmonary edema or instability that in the judgement of the operator preclude participation in the trial)
Exclusion criteria
1.Younger than 18 years of age
2.Hospitalization with a primary diagnosis of acute myocardial infarction (AMI) previously or has evidence of previous Q-wave infarct
3.Left main coronary artery culprit lesion
4.Additional stenosis in the LAD for which PCI or CABG is likely to be needed in the next 6 months and which is not treated during the index procedure
5.Cardiogenic shock (systolic blood pressure *90 mmHg in spite of conservative measures) or pulmonary edema (O2 saturation <90% by pulse oximetry and the presence of rales or crackles)
6.Cardiac arrest requiring chest compression or resuscitation
7.Anatomical complications limit capacity to place PICSO Impulse device or achieve stable catheter placement or occlude coronary sinus
8.Known renal disease (GFR < 30 mL/min/1.73m2) or dialysis
9.History of stroke, TIA or reversible ischemic neurological disease within last 6 months
10.Left bundle branch block
11.Known contra-indication for magnetic resonance imaging (Metallic implant precluding MRI, claustrophobia, obesity precluding MRI, etc.)
12.Presence of any lead in the coronary sinus
13.Active or treated malignancies in the last 12 months
14.Previous coronary artery bypass graft surgery
15.Known severe anemia (Hgb < 10 g/dL or < 6.2 mmol/L)
16.Known platelet count < 100,000, known coagulopathy or bleeding diathesis, or unwilling to accept transfusions
17.Participation in another ongoing clinical study
18.Women of child-bearing age
19.Non-cardiac comorbidities and life expectancy < 1 year
20.Legal incompetence
21.A condition that, in the opinion of the Investigator, precludes participation, including compliance with all follow-up procedures
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 |
|---|---|
| CCMO | NL37323.018.11 |