NCT01493037

Brief Summary

A prospective multi-center study in which patients with an acute heart attack (in the left anterior descending artery) with ECG changes (ST segment elevation) receive angioplasty followed by stent placement and 90 minutes of PICSO treatment. This is a proof of concept study designed to document the safety and feasibility of the Pressure Controlled Intermittent Coronary Sinus Occlusion (PICSO) Impulse system.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Last Updated

July 16, 2014

Status Verified

July 1, 2014

Enrollment Period

2.2 years

First QC Date

December 13, 2011

Last Update Submit

July 15, 2014

Conditions

ST Elevation (STEMI) Myocardial Infarction

Keywords

STEMIPICSOCoronary SinusInvolving Left Anterior Descending Coronary Artery

Outcome Measures

Primary Outcomes (1)

  • Successful delivery of PICSO treatment

    Assessment of the feasibiity of PICSO in STEMI patients defined as the successful elivery of the PICSO catheter and the successful administration of PICSO treatment for 90 minutes

    90 minutes

Secondary Outcomes (6)

  • MRI measurement of infarct size

    4 months

  • Assessment of left ventricular function

    4 months

  • Assessment of microvascular perfusion

    4 months

  • Resolution of ST-segment elevation

    24 hours

  • Measurement of ST segment time curve area

    3 hours

  • +1 more secondary outcomes

Study Arms (1)

PICSO

OTHER

PICSO treatment for 90 minutes

Device: PICSO (Pressure-controlled Intermittent Coronary Occlusion

Interventions

PICSO (Pressure-controlled Intermittent Coronary OcclusionDEVICE

The PICSO catheter has a balloon which is placed in the coronary sinus via the femoral vein. The balloon is inflated and deflated at intervals calculated by an algorithm and adjusted according to the patient's own coronary sinus pressure plateau.

Also known as: PICSO Impulse Catheter, PICSO Impulse Console
PICSO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First time anterior STEMI defined by the following:
  • Symptoms of myocardial ischemia \> 30 minutes and \< 12 hours
  • ST-segment elevation \> 1mm (\> 0.1 mV) in two contiguous precordial leads in the anterior territory on a 12-lead ECG
  • 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 investigator preclude participation in the trial)

You may not qualify if:

  • Younger than 18 years of age
  • Hospitalization with a primary diagnosis of acute myocardial infarction (AMI) previously or has evidence of previous Q-wave infarct
  • Left main coronary artery culprit lesion
  • 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
  • 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)
  • Cardiac arrest requiring chest compression or resuscitation
  • Anatomical complications limit capacity to place PICSO Impulse device or achieve stable catheter placement or occlude coronary sinus
  • Known renal disease (GFR \< 30 mL/min/1.73m2) or dialysis
  • History of stroke, TIA or reversible ischemic neurological disease within last 6 months
  • Left bundle branch block
  • Known contra-indication for magnetic resonance imaging (Metallic implant precluding MRI, claustrophobia, obesity precluding MRI, etc.)
  • Presence of any lead in the coronary sinus
  • Active or treated malignancies in the last 12 months
  • Previous coronary artery bypass graft surgery
  • Known severe anemia (Hgb \< 10 g/dL or \< 6.2 mmol/L)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Academic Medical Center - University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Amphia Hospital

Breda, Netherlands

Location

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionMyocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Jan J Piek, Professor

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2011

First Posted

December 15, 2011

Study Start

December 1, 2011

Primary Completion

March 1, 2014

Last Updated

July 16, 2014

Record last verified: 2014-07

Locations

NL(2)