Distal Evaluation of Functional performance with Intravascular sensors to assess the Narrowing Effect - Combined pressure and Doppler FLOW velocity measurements

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

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
grafts);
• 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
willingness to sign a written informed consent.

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).,
3.2.7 Recent (within 3 weeks prior to cardiac catheterization) ST-segment
elevation myocardial infarction (STEMI) in any arterial distribution (not
specifically target lesion)., 3.2.8 Culprit lesions (based on clinical judgment
of the operator) for either STEMI or non-STEMI cannot be included., 3.2.9
Severe cardiomyopathy (LV ejection fraction <30%)., 3.2.10 Planned need for
cardiac surgery (for example, valve surgery, treatment of aortic aneurysm, or
septal myomectomy)., General exclusions:
3.2.11 A life expectancy of less than 2 years., 3.2.12 Inability to sign an
informed consent, due to any mental condition that renders the subject unable
to understand the nature, scope, and possible consequences of the trial or due
to mental retardation or language barrier., 3.2.13 Potential for non-compliance
towards the requirements for follow-up visits., 3.2.14 Participation or planned
participation in another cardiovascular clinical trial before completing the 24
month follow-up.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint<br /><br>• 24-month rate of major adverse cardiac events:<br /><br>o all-cause death<br /><br>o documented myocardial infarction<br /><br>o unplanned, urgent revascularization (not cross-over revascularization)<br /><br>o elective revascularization (both non-urgent and repeat procedures)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints<br /><br>• Canadian Cardiovascular Society (CCS) anginal class (or freedom from angina)<br /><br>at 6, 12, 18, and 24 months (then 5 and potentially also 10 years depending on<br /><br>resources)<br /><br>• Number of anti-anginal medications at the same time points as CCS angina class<br /><br>• Cerebrovascular events at any time<br /><br>• Bland-Altman bias, limits of agreement, and reproducibility coefficient for<br /><br>repeated physiology measurements<br /><br>• Procedure time from anticoagulation to completion of physiologic measurements<br /><br>• Number of tracings excluded by core physiology lab due to noise, artifact, or<br /><br>loss of signal</p><br>