Stable AnginaPhase 2PICSONCT01308125
Safety And Feasibility Study Of Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO) In Patients With Coronary Artery Disease Undergoing Native Vessel Intervention
A Phase 2 study testing PICSO in people with Stable Angina, run by Miracor Medical SA at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina
- What is being tested?
- PICSO
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2010to Apr 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
1 Background Good collateral flow in case of obstructive coronary artery disease and acute myocardial 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 peri-procedural and acute myocardial infarction without the increased risk of bleeding such as is encountered with gp2b3a inhibitors. This study is designed to evaluate the safety and feasibility of PICSO in patients with stable coronary artery disease and experimental short coronary artery occlusion.
- Objective The purpose of the study is to determine whether PICSO is safe and feasible with a femoral approach, and in what amount of cases PICSO is effective to increase collateral flow index (CFI). In this study an adapted collateral flow pressure index (CFpI) will be used and is calculated as the ratio of the distal LAD pressure during LAD balloon occlusion (PLADoccl.) and the Aortic pressure (Pao). CFI>30% has been shown in several studies to be a significant predictor of inducible ischemia as measured by intracoronary ST-segment changes. The study is a non-randomized single centre trial using a Bayesian statistical model.
- Specific This study is a study in 10 elective patients with coronary artery disease assessing the safety and feasibility of adjunctive PICSO treatment during PCI using a femoral vein approach.
Together with the preclinical experience using the Miracor technology, we therefore believe that the planned cohort of 10 patients is sufficient to corroborate earlier experiences on the safety of the procedure as well as present technology.
For the effectiveness, 10 sets of measurements before and after the procedure in each patient will provide insight into the clinical significance since each patient will serve as her or his control.
Study end-points
3.1 Primary endpoints
- Duration from successful femoral vein cannulation until successful placement of PICSO Impulse catheter into the Coronary Sinus.
- Relative increase in collateral flow pressure index (CFpI) during LAD occlusion with and without PICSO.
3.2 Secondary endpoints
- Number of patients reaching collateral flow pressure index (CFpI) higher than 30% during PICSO.
- Quantitative evaluation of pre-condition effect on relative increase of CFpI.
- The change of ST segment as recorded at Intra coronary ECG measures during balloon inflation.
3.3 Primary safety endpoints
- The patients are hemodynamic stable during PICSO.
- Elevation of coronary sinus pressure
- The 30 days MACE is comparable to other patients undergoing PCI.
- Stroke
- Bleeding
- Inflammation
- New onset of an acute coronary syndrome or newly documented heart failure, requiring therapy or hospitalization
- Pulmonary embolism
- Coronary sinus permanent occlusion
- Death
- Other Adverse Events
- No reported Adverse Events caused by PICSO
- Conditions
- Stable Angina
- Being tested
- PICSO
- Keywords
- Stable Angina, Coronary artery disease, PCI, Reperfusion, Myocardial Infarction, collateral flow pressure index, CFpI, pressure controlled intermittent coronary sinus occlusion, PICSO
- Medical subject headings
- Angina, Stable, Coronary Artery Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICSOProcedure or surgery
Also called PICSO Impulse System, PICSO Impulse Console, PICSO Impulse Catheter
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
No reported Adverse Events caused by PICSO
Measured: 30 days
Secondary outcomes (8)
The 30 days MACE is comparable to other patients undergoing PCI.
Number of patients of reported ADE described as:
- Stroke
- Bleeding
- Inflammation
- New onset of an acute coronary syndrome or newly documented heart failure, requiring therapy or hospitalization
- Pulmonary embolism
- Coronary sinus permanent occlusion
- Death
- Other Adverse Events
Measured: 30 days after intervention
The patients are hemodynamic stable during PICSO.
The hemodynamic is constantly monitored during the whole intervention and will be qualified by:
Arterial pressure, LAD pressure, LAD velocity, Coronary Sinus pressure, ECG
Measured: 6 hours (during the whole intervention)
Relative increase in collateral flow pressure index (CFpI) during LAD occlusion with and without PICSO.
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.
Measured: 6 hours (during the whole intervention)
The change of ST segment as recorded at Intra coronary ECG measures during balloon inflation.
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.
Measured: 6 hours (during the whole intervention)
Number of patients reaching collateral flow pressure index (CFpI) higher than 30% during PICSO.
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.
Measured: 6 hours (during the whole intervention)
Quantitative evaluation of pre-condition effect on relative increase of CFpI.
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.
Measured: 6 hours (during the whole intervention)
Duration from successful femoral vein cannulation until successful placement of PICSO Impulse catheter into the Coronary Sinus.
For each case the time will be captured and the average time will be calculated from all enrolled cases.
Measured: 1 hours (at the begin of the intervention)
Intermittent elevation of coronary sinus pressure
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.
Measured: 6 hours (during the whole intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2011 (estimated)
- Study startOct 2010
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miracor Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan J. Piek, Prof, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308125
- Sponsor's protocol ID
- CIP 2009-03 PREPARE PICSO
- Acronym
- PICSO
- Status last verified
- Apr 2012
- First submitted
- 3 Feb 2011
- Last updated
- 23 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01308125
- Acronym / sponsor ID
- PICSO / CIP 2009-03 PREPARE PICSO
- Conditions
- Stable Angina
- Keywords
- Stable Angina, Coronary artery disease, PCI, Reperfusion, Myocardial Infarction, collateral flow pressure index, CFpI, pressure controlled intermittent coronary sinus occlusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Miracor Medical SAIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 3 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
1 Background Good collateral flow in case of obstructive coronary artery disease and acute myocardial 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 peri-procedural and acute myocardial infarction without the increased risk of bleeding such as is encountered with gp2b3a inhibitors. This study is designed to evaluate the safety and feasibility of PICSO in patients with stable coronary artery disease and experimental short coronary artery occlusion.
- Objective The purpose of the study is to determine whether PICSO is safe and feasible with a femoral approach, and in what amount of cases PICSO is effective to increase collateral flow index (CFI). In this study an adapted collateral flow pressure index (CFpI) will be used and is calculated as the ratio of the distal LAD pressure during LAD balloon occlusion (PLADoccl.) and the Aortic pressure (Pao). CFI>30% has been shown in several studies to be a significant predictor of inducible ischemia as measured by intracoronary ST-segment changes. The study is a non-randomized single centre trial using a Bayesian statistical model.
- Specific This study is a study in 10 elective patients with coronary artery disease assessing the safety and feasibility of adjunctive PICSO treatment during PCI using a femoral vein approach.
Together with the preclinical experience using the Miracor technology, we therefore believe that the planned cohort of 10 patients is sufficient to corroborate earlier experiences on the safety of the procedure as well as present technology.
For the effectiveness, 10 sets of measurements before and after the procedure in each patient will provide insight into the clinical significance since each patient will serve as her or his control.
Study end-points
3.1 Primary endpoints
- Duration from successful femoral vein cannulation until successful placement of PICSO Impulse catheter into the Coronary Sinus.
- Relative increase in collateral flow pressure index (CFpI) during LAD occlusion with and without PICSO.
3.2 Secondary endpoints
- Number of patients reaching collateral flow pressure index (CFpI) higher than 30% during PICSO.
- Quantitative evaluation of pre-condition effect on relative increase of CFpI.
- The change of ST segment as recorded at Intra coronary ECG measures during balloon inflation.
3.3 Primary safety endpoints
- The patients are hemodynamic stable during PICSO.
- Elevation of coronary sinus pressure
- The 30 days MACE is comparable to other patients undergoing PCI.
- Stroke
- Bleeding
- Inflammation
- New onset of an acute coronary syndrome or newly documented heart failure, requiring therapy or hospitalization
- Pulmonary embolism
- Coronary sinus permanent occlusion
- Death
- Other Adverse Events
- No reported Adverse Events caused by PICSO
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICSOAlso: PICSO Impulse System, PICSO Impulse Console, PICSO Impulse Catheter* 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. | Procedure or surgery | – |
Primary outcome
No reported Adverse Events caused by PICSO
Time frame: 30 days
8 secondary outcomes
The 30 days MACE is comparable to other patients undergoing PCI.
Time frame: 30 days after intervention
The patients are hemodynamic stable during PICSO.
Time frame: 6 hours (during the whole intervention)
Relative increase in collateral flow pressure index (CFpI) during LAD occlusion with and without PICSO.
Time frame: 6 hours (during the whole intervention)
The change of ST segment as recorded at Intra coronary ECG measures during balloon inflation.
Time frame: 6 hours (during the whole intervention)
Number of patients reaching collateral flow pressure index (CFpI) higher than 30% during PICSO.
Time frame: 6 hours (during the whole intervention)
Quantitative evaluation of pre-condition effect on relative increase of CFpI.
Time frame: 6 hours (during the whole intervention)
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)
Intermittent elevation of coronary sinus pressure
Time frame: 6 hours (during the whole intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2012.
Related trials for Stable Angina
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
Recruiting
Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
Angina (Stable), Coronary Artery Disease(CAD)
Active, not recruitingObservational study
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Angina Pectoris, Angina Pectoris, Stable
RecruitingObservational study
Identification of Lesion Characteristics in Coronary Plaques Using Multimodality Intravascular Imaging and Novel Photon-counting CT in Stable Angina
Coronary Artery Disease (CAD), Stable Angina Pectoris
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan J. Piek, Prof principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PICSO in people with Stable Angina, run by Miracor Medical SA at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No reported Adverse Events caused by PICSO (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2012.