NL-OMON50216
Recruiting
Not Applicable
Distal Evaluation of Functional performance with Intravascular sensors to assess the Narrowing Effect - Combined pressure and Doppler FLOW velocity measurements - DEFINE FLOW
niversity of Texas Medical School at Houston0 sites100 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- atherosclerosis
- Sponsor
- niversity of Texas Medical School at Houston
- Enrollment
- 100
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •3\.1 Inclusion Criteria, 3\.1\.1 Age \>\= 18 years., 3\.1\.2 Eligible for PCI based on
- •local practice standards during the current procedure (PCI cannot be staged).,
- •3\.1\.3 At least one epicardial stenosis of \>\=50% diameter (by visual or
- •quantitative assessment) and meeting the following criteria as determined by
- •the operator based on either a prior or the current diagnostic angiogram:
- •\<100% diameter (not a chronic, total occlusion);
- •in a native coronary artery (including side branches but excludes bypass
- •of \>\=2\.5mm reference diameter (near the level of the stenosis);
- •and supplies sufficiently viable myocardium (exclude regions of known, prior,
- •transmural myocardial infarction)., 3\.1\.4 Ability to understand and the
Exclusion Criteria
- •Anatomic exclusions:, 3\.2\.1 Prior CABG., 3\.2\.2 Preferred treatment strategy for
- •revascularization would be CABG based on local practice standards., 3\.2\.3 Left
- •main coronary artery disease requiring revascularization., 3\.2\.4 Extremely
- •tortuous or calcified coronary arteries precluding intracoronary physiologic
- •measurements. Operators may also exclude subtotal or similar high\-grade
- •lesions, which in their judgment may be threatened by ComboWire placement.,
- •3\.2\.5 Known severe LV hypertrophy (septal wall thickness at echocardiography of
- •\>13 mm)., Clinical exclusions:
- •3\.2\.6 Inability to receive intravenous adenosine (for example, severe reactive
- •airway disease, marked hypotension, or high\-grade AV block without pacemaker).,
Outcomes
Primary Outcomes
Not specified
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