Safety And Feasibility Study Of Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO) In Patients With Coronary Artery Disease Undergoing Native Vessel Intervention

NCT01308125 | Completed Phase 2

• 1 other identifier: CIP 2009-03 PREPARE PICSO
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Stable Angina; Coronary artery disease; PCI; Reperfusion; Myocardial Infarction; collateral flow pressure index; CFpI; pressure controlled intermittent coronary sinus occlusion; PICSO

Outcome Measures

Primary Outcomes (1)

• No reported Adverse Events caused by PICSO

  30 days

Secondary Outcomes (8)

• The 30 days MACE is comparable to other patients undergoing PCI.

  30 days after intervention

• The patients are hemodynamic stable during PICSO.

  6 hours (during the whole intervention)

• Relative increase in collateral flow pressure index (CFpI) during LAD occlusion with and without PICSO.

  6 hours (during the whole intervention)

• The change of ST segment as recorded at Intra coronary ECG measures during balloon inflation.

  6 hours (during the whole intervention)

• Number of patients reaching collateral flow pressure index (CFpI) higher than 30% during PICSO.

  6 hours (during the whole intervention)

Interventions

PICSO PROCEDURE

* 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Miracor Medical SA: lead

Study Sites (1)

Academic Medical Center Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Angina, Stable; Coronary Artery Disease; Myocardial Infarction

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Jan J. Piek, Prof

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: March 3, 2011
• Study Start: October 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 23, 2012

Record last verified: 2012-04

Locations

NL (1)