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Safety And Feasibility Study Of Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO) In Patients With Coronary Artery Disease Undergoing Native Vessel Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Miracor Medical Systems
ClinicalTrials.gov Identifier:
NCT01308125
First received: February 3, 2011
Last updated: April 20, 2012
Last verified: April 2012
History of Changes
  Purpose

Pressure intermittent coronary sinus occlusion (PICSO) in patients with coronary artery disease improves collateral flow index to higher than 30%. PICSO used in this patient population is safe, feasible and effective. Safety, feasibility and effectiveness will be tested by periprocedural and logistic data.


Condition Intervention Phase
Stable Angina
 Procedure: PICSO
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PREPARE PICSO A Study To Evaluate The Safety And Feasibility Of Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO) In Patients With Coronary Artery Disease Undergoing Native Vessel Intervention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Miracor Medical Systems:

Primary Outcome Measures:
  • No reported Adverse Events caused by PICSO [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The 30 days MACE is comparable to other patients undergoing PCI. [ Time Frame: 30 days after intervention ] [ Designated as safety issue: Yes ]

    Number of patients of reported ADE described as:

    1. Stroke
    2. Bleeding
    3. Inflammation
    4. New onset of an acute coronary syndrome or newly documented heart failure, requiring therapy or hospitalization
    5. Pulmonary embolism
    6. Coronary sinus permanent occlusion
    7. Death
    8. Other Adverse Events

  • The patients are hemodynamic stable during PICSO. [ Time Frame: 6 hours (during the whole intervention) ] [ Designated as safety issue: Yes ]

    The hemodynamic is constantly monitored during the whole intervention and will be qualified by:

    Arterial pressure, LAD pressure, LAD velocity, Coronary Sinus pressure, ECG


  • Relative increase in collateral flow pressure index (CFpI) during LAD occlusion with and without PICSO. [ Time Frame: 6 hours (during the whole intervention) ] [ Designated as safety issue: No ]
    A ComboWire (VolcanoCorp, CA, USA) will be advanced in the center lumen of an occlusion balloon. This will allow performing the measurements below the experimental occlusion.

  • The change of ST segment as recorded at Intra coronary ECG measures during balloon inflation. [ Time Frame: 6 hours (during the whole intervention) ] [ Designated as safety issue: No ]
    The presence or absence of ECG signs of myocardial ischemia during balloon occlusion will also be assessed on-line by means of the ST segment changes >0.1mV present on an intracoronary ECG lead obtained from the angioplasty guide wire placed distal to the stent (outside the OTW balloon) in the region on interest.

  • Number of patients reaching collateral flow pressure index (CFpI) higher than 30% during PICSO. [ Time Frame: 6 hours (during the whole intervention) ] [ Designated as safety issue: No ]
    A ComboWire (VolcanoCorp, CA, USA) will be advanced in the center lumen of an occlusion balloon. This will allow performing the measurements below the experimental occlusion, see also above.

  • Quantitative evaluation of pre-condition effect on relative increase of CFpI. [ Time Frame: 6 hours (during the whole intervention) ] [ Designated as safety issue: No ]
    A ComboWire (VolcanoCorp, CA, USA) will be advanced in the center lumen of an occlusion balloon. This will allow performing the measurements below the experimental occlusion. A comparision will be made between the LAD occlusion phase with or without PICSO.

  • Duration from successful femoral vein cannulation until successful placement of PICSO Impulse catheter into the Coronary Sinus. [ Time Frame: 1 hours (at the begin of the intervention) ] [ Designated as safety issue: Yes ]
    For each case the time will be captured and the average time will be calculated from all enrolled cases.

  • Intermittent elevation of coronary sinus pressure [ Time Frame: 6 hours (during the whole intervention) ] [ Designated as safety issue: No ]
    The coronary sinus pressure will be recorded during the whole intervention. The relative mean and max. increase during the PICSO-phase will be evaluated per Patient and over all cases.


Enrollment: 10
Study Start Date: October 2010
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: PICSO
    • Baseline (hemodynamic) measurement
    • Intra coronary
    • Blood sampling
    • LAD occlusion: for 3 min or until pain with and without PICSO
    • Break recovery: the patient can recover from pain for 3 min
    • CFIp: by a ComboWire advanced in the center lumen of an occlusion balloon.
    • PICSO: start automatically and continued for 10 min.
    • PCI/PICSO: concomitantly for the whole duration of the PCI intervention.
    • 24h Follow up: additional blood samples every 6 hours (4 times)
    • 30 days follow up.
    Other Names:
    • PICSO Impulse System
    • PICSO Impulse Console
    • PICSO Impulse Catheter
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects (men or women) at least 18 years of age and
  • Coronary artery disease as assessed by angiography and
  • Clinical indication for PCI and
  • Able to understand content of and willing to provide written informed consent

Exclusion Criteria:

  • Active and or treated malignancies within 12 months prior to Visit 1
  • Anatomical complications (e.g. The system in not able to effectively occlude the coronary sinus)
  • Presence of significant colleteral flow supplying the target vessel (Rentrop >1)
  • 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 would not be in the best interest of the subject
  • Bleeding or perforation during PCI, pericardial effusion and/or hematoma
  • Cardiac arrest or arrhythmia requiring chest compressions or cardiopulmonary resuscitation
  • Cardiogenic shock (Cardiac Index <1.8 L/min/meter-squared or as 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≤30 mL/min/1,73m2)
  • Coronary Sinus electrode in place
  • Acute ST elevation myocardial infarction
  • Previous Q-wave myocardial infarction in the target area
  • History of acute myocardial infarction within 72h prior to screening
  • Ejection fraction <20%
  • History of stroke, any sequelae of a transient ischemic attack (TIA), 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 rhythm
  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308125

Locations
Netherlands
Academic Medical Center Amsterdam
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
Miracor Medical Systems
Investigators
Principal Investigator: Jan J. Piek, Prof Academic Medical Center, Amsterdam
  More Information

No publications provided

Responsible Party: Miracor Medical Systems
ClinicalTrials.gov Identifier: NCT01308125     History of Changes
Other Study ID Numbers: CIP 2009-03 PREPARE PICSO
Study First Received: February 3, 2011
Last Updated: April 20, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Miracor Medical Systems:
Stable Angina
Coronary artery disease
PCI
Reperfusion
Myocardial Infarction
 collateral flow pressure index
CFpI
pressure controlled intermittent coronary sinus occlusion
PICSO

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina Pectoris
Heart Diseases
Cardiovascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013