Optical Imaging Measurement of Intravascular Solution Efficacy Trial (OPTIMISE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University Hospital Case Medical Center
Sponsor:
Information provided by (Responsible Party):
Dr. Vikram S. Kashyap, M.D., University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01743872
First received: September 26, 2012
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

Iodinated contrast is the current gold standard for infrainguinal angiography imaging in patients without renal insufficiency and has also been used with intravascular Optical Coherence Tomography (iOCT) to improve image quality in human coronary arteries as well as carotid arteries. The current debate in the literature for iOCT medium is between iodinated contrast and dextran and CO2 may offer a superior method of iOCT imaging during lower extremity occlusive disease interventions.

The investigators hypothesize that the CO2 medium injection during iOCT data acquisition is feasible and will produce at least the same quality of imaging as that obtained with contrast or dextran without causing the problems of volume overload and renal toxicity seen with the two latter mediums.

Primary Outcomes Measured

  • Quality: Cumulative number of clear image frame (CIF) through the entire 54mm length segment.
  • Quantitative: Calculations of the area and diameter of each segment will be measured to determine if index of refraction has any effect between the three mediums to be tested.

The investigators expect to find little difference between all three iOCT mediums and hope to conclude that CO2 offers a superior side effect profile for iOCT imaging in the lower extremity arterial system.


Condition Intervention Phase
Peripheral Artery Disease
Procedure: iOCT
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Optical Imaging Measurement of Intravascular Solution Efficacy Trial

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Quality of Images [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The images will be taken intra-operatively during a procedure that will last approximately 1-2 hours. Cumulative number of clear image frame (CIF) through the entire 54mm length segment will be assessed in the imaging core lab by the investigators. Patients will be seen in clinic for routine follow-up at one month.


Secondary Outcome Measures:
  • Quantitative Measures [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The images will be taken intra-operatively during a procedure that will last approximately 1-2 hours. Calculations of the area and diameter of each segment will be measured to determine if index of refraction has any effect between the three mediums to be tested. Patients will be seen in clinic for routine follow-up at one month.


Estimated Enrollment: 25
Study Start Date: September 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Contrast Injection
Media #1: IV Contrast (Omnipaque 350) will be continuously injected at a rate range of 2.5-6ml/s for a maximum of 5 seconds. (Volume range of 12.5- 30ml) Intervention protocol will be followed per Cross-Reference Intervention.
Procedure: iOCT
Arterial access will performed by the operating surgeon. An aortic and infrainguinal angiogram using the standard method of intravenous iodinated contrast under digital subtraction fluoroscopy will be conducted in the usual manner according to the vascular surgeon. A 54 mm section of Superficial Femoral Artery will be chosen for study imaging. An intervention sheath or injection catheter will be placed just proximal to the area of interest. An 0.014" wire will be passed distal to the area of interest. The patient will then undergo OCT of this 54mm section with each of the three mediums below using a continuous flushing method through injection catheter. All OCT imaging will be collected at a rate of 25mm/sec. In the event of a subsequent procedure, OCT imaging will again be performed.
Active Comparator: Dextran Injection
Media #2: Dextran 40 Solution will be continuously injected at a rate range of 2.5-6ml/s for a maximum of 5 seconds. (Volume range of 12.5- 30ml. Intervention protocol will be followed per Cross-Reference Intervention.
Procedure: iOCT
Arterial access will performed by the operating surgeon. An aortic and infrainguinal angiogram using the standard method of intravenous iodinated contrast under digital subtraction fluoroscopy will be conducted in the usual manner according to the vascular surgeon. A 54 mm section of Superficial Femoral Artery will be chosen for study imaging. An intervention sheath or injection catheter will be placed just proximal to the area of interest. An 0.014" wire will be passed distal to the area of interest. The patient will then undergo OCT of this 54mm section with each of the three mediums below using a continuous flushing method through injection catheter. All OCT imaging will be collected at a rate of 25mm/sec. In the event of a subsequent procedure, OCT imaging will again be performed.
Active Comparator: CO2 Injection
Media #3: Carbon Dioxide (CO2) will be injected with large volume hand injection syringe as per the usual protocol. This be done with particular attention to avoid air in the closed system. In addition to supine, there is also an option that the patient's distal limb may be elevated to improve the flow of CO2 during injection. The surgeon will also wait at least 2 minutes between each CO2 injection to allow any potentially trapped CO2 to dissolve. A range of 20-60 ml will be used with each hand injection based on the data from the initial 5-10 pilot patients. Intervention protocol will be followed per Cross-Reference Intervention.
Procedure: iOCT
Arterial access will performed by the operating surgeon. An aortic and infrainguinal angiogram using the standard method of intravenous iodinated contrast under digital subtraction fluoroscopy will be conducted in the usual manner according to the vascular surgeon. A 54 mm section of Superficial Femoral Artery will be chosen for study imaging. An intervention sheath or injection catheter will be placed just proximal to the area of interest. An 0.014" wire will be passed distal to the area of interest. The patient will then undergo OCT of this 54mm section with each of the three mediums below using a continuous flushing method through injection catheter. All OCT imaging will be collected at a rate of 25mm/sec. In the event of a subsequent procedure, OCT imaging will again be performed.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • English speaking
  • Scheduled to undergo an infrainguinal angiogram and/or endovascular procedure as determined by a vascular surgery specialist
  • Superficial Femoral Artery diseased segment

Exclusion Criteria:

  • Acute or Chronic Renal insufficiency with Cr >1.5
  • Chronic obstructive pulmonary disease
  • Congestive heart failure (American Heart Association C lass III or IV)
  • Acute limb ischemia, defined by a significant change in symptoms (one category on the Rutherford scale within the previous 14 days)
  • Concurrent oral anticoagulant therapy that cannot be safely withheld
  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: NCT01743872

Contacts
Contact: Vikram S Kashyap, MD 216-844-3013 vikram.kashyap@uhhospitals.org
Contact: Hiram Bezerra, MD hiram.bezerra@uhhospitals.org

Locations
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Vikram S Kashyap, MD    216-844-1631    Vikram.Kashyap@UHhospitals.org   
Principal Investigator: Vikram S Kashyap, MD         
Sub-Investigator: Hiram Bezerra, MD         
Sub-Investigator: Ryan O Lakin, MD         
Sub-Investigator: Matthew T Allemang, MD         
Sub-Investigator: Benjamin A Eslahpazir, BS         
Sponsors and Collaborators
University Hospital Case Medical Center
  More Information

Additional Information:
Publications:

Responsible Party: Dr. Vikram S. Kashyap, M.D., Chief, Division of Vascular Surgery and Endovascular Intervention, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT01743872     History of Changes
Other Study ID Numbers: OPTIMISE
Study First Received: September 26, 2012
Last Updated: December 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospital Case Medical Center:
Optical Coherence Tomography
Contrast
Dextran
Carbon Dioxide
Imaging
Catheter
Lower Extremity Artery

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014