Pressure Controlled Intermittent Coronary Sinus Occlusion as an Adjunct to PCI in Acute Coronary Syndrome.

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Miracor Medical Systems
Sponsor:
Information provided by (Responsible Party):
Miracor Medical Systems
ClinicalTrials.gov Identifier:
NCT02197325
First received: July 16, 2014
Last updated: August 2, 2014
Last verified: August 2014
  Purpose

The purpose of this research study is to find out whether PICSO (Pressure Controlled Coronary Sinus Occlusion), given concomitant to (NSTEMI) or following (STEMI) primary PCI and stenting, can improve final infarct size and myocardial function.

ACS patients, NSTEMI and STEMI, with a culprit lesion in the LAD will be treated according to standard treatment, PCI followed by stent placement, with or without PICSO therapy. In NSTEMI patients, PICSO therapy will be given during PCI and stenting for a minimum of 30 minutes or the duration of the PCI and stent procedure. In STEMI patients PICSO therapy will be given after successful primary percutaneous coronary intervention of a left anterior descending coronary artery culprit lesion. PICSO therapy is initiated prior to stent deployment and continued during stenting. The functional efficacy measures, related to the PICSO duration and coronary sinus pressures, will be stored on the PICSO Impulse console and analysed offline. The clinical efficacy measures, cardiac enzyme release during 24 hour following PCI, cardiac function, infarct size and level of microvascular obstruction will be assessed by cMRI. Patients will be followed for a maximum of 4 months after the primary PCI procedure


Condition Intervention
Acute Coronary Syndrome
Device: PICSO

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pressure Controlled Intermittent Coronary Sinus Occlusion as an Adjunct to PCI in Acute Coronary Syndrome. (An Observational Study Evaluating the Effect of PICSO Treatment Concomitant to pPCI in Patients With Anterior NSTEMI or Following pPCI in STEMI)

Further study details as provided by Miracor Medical Systems:

Primary Outcome Measures:
  • Change in Infarct Size assessed by cardiac MRI [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
    Efficacy of PICSO treatment as assessed by means of infarct size reduction assessment, 4-months vs. 1 week post-primary PCI in comparison with a matched non-PICSO parallel control group


Secondary Outcome Measures:
  • Enzymatic Infarct Size [ Time Frame: 12 hours post PCI ] [ Designated as safety issue: No ]
    Peak Troponin level 12 hours after pPCI, in comparison with a matched non-PICSO parallel control group

  • Level of Microvascular Obstruction assessed by cardia MRI [ Time Frame: 2-5 days post PCI ] [ Designated as safety issue: No ]
    Microvascular Obstruction assessed by cardiac MRI on 2-5 days post pPCI

  • Absolute Infarct size assessment by cardiac MRI [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
    Infarct size assessment by cardiac MRI (presented as % of Area at Risk, AAR, and % of LV) at 2-5 days and 120 ± 14 days post-primary PCI in comparison with a matched non-PICSO parallel control group.

  • MACE [ Time Frame: baseline to 4 months ] [ Designated as safety issue: No ]
    Occurrence of major adverse cardiac events (MACE) during follow-up


Estimated Enrollment: 60
Study Start Date: October 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PICSO
Participants enrolled in the PICSO treatment Group will be treated with PICSO concomitant to pPCI in patients with anterior non ST-segment Elevation Myocardial Infarction or following pPCI in ST-segment Elevation Myocardial Infarction
Device: PICSO
Pressure controlled Intermittent Coronary Pressure Occlusion
Other Name: PICSO Impulse System
No Intervention: Parallel control
Participants enrolled in will receive treatment based on the standard guidelines for treatment of a myocardial infarction.

Detailed Description:

The study is designed to evaluate the effect of PICSO treatment concomitant to or following primary PCI in patients with anterior non ST-segment Elevation Myocardial Infarction or ST-segment Elevation Myocardial Infarction, in patients with a culprit lesion in the LAD on Infarct Size and myocardial function. There will be 2 phases in this study.

  1. Phase 1: only NSTEMI patients will be recruited.
  2. Phase 2: only STEMI patients will be recruited.

Phase 1 During Phase 1 of the study only NSTEMI patients will be recruited. After having given informed consent the patient will be scheduled for pPCI and stent placement. On the day of the procedure the PICSO catheter will be placed as described below (refer to PICSO Impulse catheter placement). After the PICSO therapy is started the standard pPCI and stent placement is performed. PICSO is continued at a minimum of 30 minutes or as long as the standard pPCI and stent placement takes.

Phase 2 During Phase 2 of the study only STEMI patients will be recruited. Immediately after successful restoration of the blood flow the PICSO Impulse catheter is introduced and placed as described below (Refer to PICSO Impulse catheter placement).

After correct positioning of the PICSO Impulse catheter, the 0,032" guide wire is removed. PICSO therapy is initiated and continued until a PICSO Quantity of 1000 mmHg is reached or a maximum of 60 minutes active treatment whatever comes first. With PICSO in treatment mode, the stent is deployed.

The clinical outcome data collected will be based on the site standards of care for NSTEMI and acute STEMI. Examinations include but are not limited to physical assessments, cardiac markers, ECG, laboratory results, x-rays, angiograms, cMRI and echocardiography.

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with first time symptoms of acute coronary syndrome (NSTEMI and STEMI)
  2. Culprit lesion in the LAD.
  3. Age range 25 - 75 years

Exclusion Criteria:

  1. Complicated PCI of an LAD culprit lesion (defined as angioplasty followed by stent placement or direct stenting with the occurrence of an adverse event(s) that would preclude further interventional procedures during the index procedure, such as major bleeding, perforation, hypotension, pulmonary edema or instability that in the judgment of the investigator precludes use of the PICSO Impulse System).
  2. Previous coronary artery bypass graft surgery
  3. History of stroke, TIA or reversible ischemic neurological disease within last 6 months
  4. Hospitalization with a primary diagnosis of acute myocardial infarction (AMI) previously or has evidence of previous Q-wave infarct
  5. Known contra-indication for magnetic resonance imaging (Metallic implant precluding MRI, claustrophobia, obesity precluding MRI, etc.)
  6. Active or treated malignancies in the last 12 months
  7. Pregnant Women
  8. Non-cardiac comorbidities and life expectancy < 1 year
  9. Use of warfarin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02197325

Locations
United Kingdom
Freeman Hospital Not yet recruiting
Newcastle, United Kingdom
Contact: Azfar Zaman, Prof.    +44 1912336161    azfar.zaman@nuth.nhs.uk   
Principal Investigator: Azfar Zaman, Prof.         
Sponsors and Collaborators
Miracor Medical Systems
Investigators
Principal Investigator: Azfar Zaman, Prof. Dr. Freeman Hospital Newcastle
  More Information

No publications provided

Responsible Party: Miracor Medical Systems
ClinicalTrials.gov Identifier: NCT02197325     History of Changes
Other Study ID Numbers: CIP2014-03
Study First Received: July 16, 2014
Last Updated: August 2, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by Miracor Medical Systems:
NSTEMI and STEMI

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014