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The PICSO ViPER study is a prospective single centre cohort study of the use of PICSO in patients presenting acute myocardial infarction and impaired function of the left ventricle and candidate to angioplasty the left anterior descending (LAD) coronary artery.
The percutaneous coronary intervention (PCI) procedure will be undertaken in a standard fashion, in accordance with the Oxford University Hospitals NHS Trust (OUHT) departmental guidelines for PCI, and includes the use of pressure wire measurements before and after stent deployment. PICSO treatment will be added on top of the conventional treatment.
The protocol will constitute of 5 main stages (that will all be performed during index angioplasty procedure). The protocol is complete at the end of the angioplasty procedure, and the patient will exit the study at this point. The five stages of the protocol are described below (for details see "Detailed Description"):
Full description
In detail, the five stages of the PICSO VIPER study include:
Stage 1: Baseline
Stage 2: PICSO treatment during pre-dilation
Stage 3: Stenting with PICSO support
• Stenting is performed as usual clinical practice while the PICSO device is active. The overall duration of PICSO will be no less than 20 minutes, up to a maximum of 45 minutes.
Stage 4: Post-stent Physiology
Stage 5
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Inclusion criteria
Exclusion criteria
Patient referred for surgical revascularization or considered for medical management of coronary disease
Planned revascularization by mean of balloon angioplasty without stenting
Patients in whom safety or clinical concerns preclude participation. These would include:
Recent PCI or admission with acute coronary syndrome in the previous 3 months before screening/enrolment
Known anaemia (Hb < 90 g/L)
Pregnant or breast-feeding females
History of stroke, TIA or reversible ischaemic neurological disease within last 6 months
Known severe renal failure (eGFR < 30 ml/min/1.73m2) or history of dialysis or renal transplant
Previous coronary bypass artery grafting
Previous PCI to LAD
Known severe valvular abnormalities
Use of warfarin
Presence of pacemaker electrode or medical device in the coronary sinus
History of inability or, in the opinion of the investigator, anticipated inability to tolerate pharmacologic stress testing (e.g. second- or third-degree AV block without a cardiac pacemaker, severe asthma, resting systolic blood pressure <90mmHg, unstable coronary disease, use of medications which may interfere with the test).
Unwilling, or unable, to give informed consent.
Primary purpose
Allocation
Interventional model
Masking
2 participants in 1 patient group
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Central trial contact
Jubin Joseph, MD, PhD; Giovanni Luigi De Maria, MD, PhD
Data sourced from clinicaltrials.gov
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