The purpose of the study is to determine whether PICSO is safe and feasible using a femoral approach, and in what amount of cases PICSO is effective to increase collateral flow index (CFI).
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Duration from successful femoral vein cannulation untill successful
placement of PICSO Impulse catheter into the Coronary Sinus.
2. Relative increase in collateral flow pressure index (CFpI) during LAD
occlusion with and without PICSO.
Secondary outcome
1. Number of patients reaching collateral flow pressure index (CFpI) higher
than 30% during PICSO.
2. Quantitative evaluation of pre-condition effect on relative increase of CFpI.
3. The change of ST segment as recorded at Intra coronary ECG measures during
balloon inflation
Background summary
Good collateral flow in case of obstructive coronary artery disease and acute
myocardial infarction has beneficial effects on morbidity and mortality [73,
74, 75]. Pressure controlled Intermittent Coronary Sinus Occlusion (PICSO)
carries a promise of improving myocardial flow, decreasing microvascular
obstruction and decreasing the rate of peri-procedural 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 will thus will be able to help us
preserve cardiac function in case of infarction.
Study objective
The purpose of the study is to determine whether PICSO is safe and feasible
using a femoral approach, and in what amount of cases PICSO is effective to
increase collateral flow index (CFI).
Study design
This study is a non-randomized single center pilot study in which patients will
act as their own controls in a cross-over design.
Intervention
Patients will be treated with PICSO. This treatment exists of PICSO catheter
placement in the coronary sinus through a femoral vein approach by using a 12F
steerable guiding catheter. During two short experimental balloon occlusions of
maximum 3 minutes (or less when chest pain occurs), CFpI of the LAD artery will
be measured with and without PICSO. During the following PCI-procedure,
PICSO-treatment wil be performed continuously.
Study burden and risks
In essence, the possible complications are the same as during a normal elective
PCI. Possible risks inherited by the use of the PICSO-catheter are:
Bleeding due to puncture of the femoral vein, chest complaints during occlusion
of the coronary artery (in which case the occlusion will be stopped
immediately), chronic occlusion or injury of the coronary sinus and pulmonary
embolism.
The burden associated with participation in this study consists of 30 minutes
of anamnesis, physical examination and ECG during first hospital admission and
an elongation of the PCI-procedure of 30 minutes for research purposes. Also,
30 days after the procedure, a consult will take place by telephone for
MACE-follow up which will take about 15 minutes
Mariannengasse 14
A-1090 Wenen
AT
Mariannengasse 14
A-1090 Wenen
AT
Listed location countries
Age
Inclusion criteria
- Subjects at least 18 years of Age
- Stable patient
- Left Anterior Descending (LAD) Stenosis as assessed by angiography
- Able to understand content of and willing to provide written informed consent
Exclusion criteria
- Active and/or treated malignancies within 12 months prior to first Visit
- Anatomical Complications (e.g. The system is not able to effectively occlude the coronary sinus)
- Presence of significant collateral flow supplying the target vessel (Rentrop 2,3)
- Any significant systemic illness or medical condition that could lead to difficulty complying with the protocol; or any concurrent condition(s) which, in the investigator's opinion, would prohibit the subject from completing the study, or in which case the study would not be in the best interest of the subject.
- Bleeding or perforation during PCI, pericardial effusion and/or hematoma
- Cardiac arrest or arrythmia requiring chest compressions or cardiopulmonary resuscitation
- Cardiogenic shock (Cardiac index <1.8 L/min/m² or assessed by the investigator), pulmonary edema (Killip Class >2), or hemodynamic instability as assessed by the investigator at the time of cardiac catheterization.
- Clinically significant renal disturbance (sMDRD calculated GFR *30mL/min/1,73m²)
- Coronary Sinus electrode in place
- Acute ST elevation myocardial infarction
- Previous Q-wave myocardial infarction within 72 hours prior to screening
- Ejection Fraction <20%
- History of stroke, any sequelea of a transient ischemic attack (TIA) or reversible ischemic neurological defect (RIND) within 6 months prior to screening
- left bundle branch block
- mitral regurgitation (MR) > grade I
- mitral stenosis
- Patient not currently in sinus rythm
- patients on cardiac resynchronization therapy (CRT) or scheduled for CRT implantation
- Patients with previous CABG or planned chronic total occlusion revascularization
- Pregnancy or active breast-feeding. Urine pregnancy tests will be performed on all women who are not post-menopausal for at least 1 year.
- registration in another interventional study
- severe anemia at baseline (hemoglobin <10 g/dl or <6.2 mmol/l)
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 | NL32821.018.10 |