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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

NCT01308125 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-04-23

No results posted yet for this study

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.

Conditions

  • Stable Angina

Interventions

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.

Sponsors & Collaborators

  • Miracor Medical SA

    lead INDUSTRY

Principal Investigators

  • Jan J. Piek, Prof · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-03-31
Completion
2011-04-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01308125 on ClinicalTrials.gov