Enrolling by invitation
Not applicable
Distal Evaluation of Functional Performance with Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting
Condition(s) studied
Coronary Artery DiseaseIschemic Heart Disease
Investigational drug(s) / intervention(s)
Philips SyncVision system with Philips pressure wiresstandard of care angiographically-guided PCI
Philips SyncVision system with Philips pressure wires: Intent to use physiologically-guided PCI using the Philips SyncVision system for determining the PCI strategy
standard of care angiographically-guided PCI: Intent to use PCI standard of care angiographically-guided PCI for determining the PCI strategy
Study summary
Multi-center, prospective, randomized controlled study comparing PCI guided by angiography versus iFR Co-Registration using commercially available Philips pressure guidewires and the SyncVision co-registration system, employing an adaptive design study for interim sample size re-estimation.
Eligibility
Inclusion Criteria:
* 1\. Adult men and women (local age of consent) who present with stable or unstable angina, or NSTEMI.
* 2\. Undergoing cardiac catheterization with planned PCI or possible ad hoc PCI
* 3\. Following angiography, PCI is indicated in at least one coronary artery\* on the basis of one or more of the following:
1. Presenting with NSTE-ACS (unstable angina with ECG changes or cardiac enzyme-positive NSTEMI) with an identified culprit lesion with DS ≥50%;
2. One or more angiographic stenoses present with ≥80% stenosis severity by visual estimation;
3. One or more angiographic stenoses present with ≥50% to \<80% stenosis severity by visual estimation and an abnormal non-invasive stress test in the distribution of the lesion(s) within the past 60 days;
4. One or more angiographic stenoses are present with ≥50% to \<80% stenosis severity by visual estimation and a spot iFR measure ≤0.89 or FFR≤0.80 for borderline iFR..
* 4 Subject is willing to comply with all scheduled visits and tests and has provided informed written consent
Exclusion Criteria:
* 1\. STEMI within 30 days
* 2\. PCI within the prior 12 months, or any PCI planned after the study procedure (other than planned staged procedures of randomized vessels which are allowed)
* 3\. Prior CABG anytime
* 4\. Silent ischemia only (i.e. no cardiac symptoms related to coronary artery disease) within the prior 4 weeks
* 5\. Documented prior iFR pullback performed in any coronary artery including during the qualifying diagnostic angiogram
* 6\. Any vessel with in-stent restenosis (ISR) requiring treatment
* 7\. Cardiogenic shock defined as systolic blood pressure \<90 mmHg for \>20 minutes not responding to fluid resuscitation, or need for inotropic, pressor, or device-based hemodynamic support
* 8\. Presence of unstable ventricular arrhythmias
* 9\. Heart rate \> 110, including uncontrolled atrial fibrillation (AF)
* 10\. Decompensated congestive heart failure (NYHA Class IV or Killip Class III or IV)
* 11\. Chronic total occlusion (CTO) of a target vessel (exception: a CTO may be present in a non-target vessel if it is supplying non-viable myocardium and there is no intent to open the CTO during the index or later procedure)
* 12\. Coronary anatomy not amenable to pressure wire manipulation due to extreme tortuosity or complexity such that it is unlikely that a pressure wire could be passed to the distal third of the three major epicardial coronary arteries
* 13\. Any angiographic giant thrombus (i.e., thrombus length \> 3x RVD at lesion)
* 14\. Any target vessel with \< TIMI III flow
* 15\. Any target lesion with a reference vessel diameter (RVD) less than 2.25mm except for within the side branch of a bifurcation lesion
* 16\. Any non-target lesion with a reference vessel diameter (RVD) greater than 2.00mm that contains an ≥80% stenosis and is not intended for treatment with PCI (other than a CTO supplying non-viable myocardium - see exclusion #11)
* 17\. Known severe aortic or mitral valve stenosis/insufficiency
* 18\. Known non-cardiovascular comorbidity resulting in lifespan \<24 months
* 19\. Known left ventricular ejection fraction ≤30%
* 20\. Estimated creatinine clearance (MDRD formula) \<30 mL/min/1.73m2 or on dialysis
* 21\. Any cardiac or non-cardiac surgical procedure planned within 12 months after enrollment, or any procedure planned within 6 months after enrollment that would necessitate discontinuation of dual antiplatelet therapy
* 22\. Known pregnancy or planning to become pregnant (women of child-bearing potential must have a negative pregnancy test within 1 week of enrollment)
* 23\. Participating in another investigational drug or device study that has not reached its primary endpoint
* 24\. Any condition such as dementia or substance abuse that may impair the patient's ability to comply with all study procedures, including medication compliance and follow-up visits
* 25\. Patient is a member of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also include university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
Primary outcome measure(s)
- Major Adverse Cardiac Events (MACE; composite of cardiac death, target vessel MI (TVMI), or ischemia-driven revascularization) or hospitalization for progressive or unstable angina at 2 years — 2 years
Trial sites (84)
| Facility | City | Region | Status |
| University of Alabama Birmingham |
Birmingham |
Alabama |
|
| Pima Heart & Vascular |
Tucson |
Arizona |
|
| Central Arkansas Veterans Healthcare System (CAVHS) |
Little Rock |
Arkansas |
|
| Glendale Adventist |
Glendale |
California |
|
| Colorado Heart and Vascular |
Lakewood |
Colorado |
|
| Yale University |
New Haven |
Connecticut |
|
| MedStar Washington Hospital Center |
Washington D.C. |
District of Columbia |
|
| Memorial Healthcare |
Hollywood |
Florida |
|
| Tampa Cardiovascular Innovations and Research |
Tampa |
Florida |
|
| Emory University Hospital |
Atlanta |
Georgia |
|
| Northeast Georgia Medical Center |
Gainesville |
Georgia |
|
| Straub Medical Center |
Honolulu |
Hawaii |
|
| Carle Foundation Hospital |
Urbana |
Illinois |
|
| Community Healthcare System |
Munster |
Indiana |
|
| University of Kansas Medical Center |
Kansas City |
Kansas |
|
| Mass General |
Boston |
Massachusetts |
|
| Brigham and Women's Hospital |
Boston |
Massachusetts |
|
| Metro Cardiology Consultants |
Coon Rapids |
Minnesota |
|
| Fairview Health Services |
Edina |
Minnesota |
|
| Washington University School of Medicine |
St Louis |
Missouri |
|
| University of Nebraska Medical Center |
Omaha |
Nebraska |
|
| Dartmouth-Hitchcock Medical Center |
Lebanon |
New Hampshire |
|
| Gates Vascular Institute |
Buffalo |
New York |
|
| Northwell Health |
Lake Success |
New York |
|
| Columbia University Medical Center |
New York |
New York |
|
| St. Francis Hospital |
Roslyn |
New York |
|
| NC Heart and Vascular Research, LLC |
Raleigh |
North Carolina |
|
| Summa Health System |
Akron |
Ohio |
|
| Cleveland Clinic |
Cleveland |
Ohio |
|
| Bryn Mawr Hospital |
Bryn Mawr |
Pennsylvania |
|
| Jefferson Einstein Medical Center |
Philadelphia |
Pennsylvania |
|
| UPMC Presbyterian |
Pittsburgh |
Pennsylvania |
|
| Lankenau Medical Center |
Wynnewood |
Pennsylvania |
|
| North Central Heart |
Sioux Falls |
South Dakota |
|
| Centennial Medical Center |
Nashville |
Tennessee |
|
| Ascension Saint Thomas |
Nashville |
Tennessee |
|
| Baylor Scott & White, The Heart Hospital Plano |
Plano |
Texas |
|
| Sentara Health |
Norfolk |
Virginia |
|
| Carilion Clinic |
Roanoke |
Virginia |
|
| Gundersen Health |
La Crosse |
Wisconsin |
|
+ 44 more sites — see the full list on the official registry below.
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