Optical Imaging Measurement of Intravascular Solution Efficacy Trial (OPTIMISE)
This study is currently recruiting participants.
Verified December 2012 by University Hospital Case Medical Center
Sponsor:
University Hospital Case Medical Center
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
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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:
MedlinePlus related topics:
Peripheral Arterial Disease
Drug Information available for:
Carbon dioxide
U.S. FDA Resources
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
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 |
Dextrans Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Plasma Substitutes Blood Substitutes |
ClinicalTrials.gov processed this record on June 18, 2013