Active Clinical Trials

Distal Evaluation of Functional Performance with Intravascular Sensors to assess the Narrowing Effect: Guided Physiologic Stenting” (DEFINE GPS)

Trial Purpose and Description

Muti-center, prospective, randomized controlled study comparing PCI guided by angiography versus iFR Co-Registration using commercially available Philips pressure guidewires and Sync Vision co-registration system, employing an adaptive design study for interim sample size re-estimation.

Inclusion Criteria:

• Adult men and women (local age of consent) who present with stable or unstable angina or NSTEMI.
• Undergoing cardiac catheterization with planned or possible ad hoc PCI
• 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 non­invasive 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

Principal Investigator

Saihari Sadanandan, MD.

CONTACT US

Allis Delafield, BS, RN.

Research Administrator

• Phone Number: (813) 232-0339
• [email protected]

IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact (IMPROVE)

Trial Purpose and Description

To assess the impact of intravascular ultrasound (IVUS) on the stent treatment of complex coronary artery disease

Inclusion Criteria

1. Subject must be at least 18 years of age
2. Subject must have evidence of myocardial ischemia (i.e. stable angina, silent ischemia, unstable angina, or acute myocardial infarction) suitable for elective PCI.
3. Patients undergoing planned stent implantation during a clinically indicated PCI procedure meeting one or more of the following criteria:

Complex lesion, with at least one target lesion planned for randomization meeting at least one of the following criteria:

1. Chronic total occlusion (CTO)
2. In-stent restenosis (ISR): The lesion must be at or within the stent margin (total stented length plus 5 mm of either edge, visual estimate).
3. Severe coronary artery calcification is defined as angiographically visible calcification on both sides of the vessel wall in the absence of cardiac motion and prior to contrast injection.
4. Long lesion is defined as the intended total stent length in any single vessel ≥28 mm in length.
5. Bifurcation lesion (Any Medina class that involves main branch disease with a side-branch ≥2.0 mm)
6. All target lesions must have a visually estimated or quantitatively assessed diameter stenosis (DS)% of either ≥70%, or ≥50% plus one or more of the following: an abnormal functional test (i.e. invasive physiology, stress test) signifying ischemia in the distribution of the target lesion or biomarker positive ACS with plaque disruption or thrombus.

Principal Investigator

Saihari Sadanandan, MD.

CONTACT US

Allis Delafield, BS, RN.

Research Administrator

• Phone Number: (813) 232-0339
• [email protected]

Trial Purpose and Description

A Phase 3, Randomized, Double-blind, Placebo-controlled, Event-driven Study to Demonstrate the Efficacy and Safety of Milvexian, a novel Oral Factor XIa Inhibitor, After a Recent Acute Coronary Syndrome

Eligibility Criteria

1. ≥18 years of age.
2. Participants must have an index event that meets all 3 of the following criteria within 7 days prior to randomization:
3. Clinical syndrome consistent with spontaneous cardiac ischemia
4. Diagnosis of ACS (i.e., STEMI, non-STEMI, or UA)
5. Cardiac biomarker elevation (e.g., troponin I, troponin T, CK-MB) above the upper limit of normal as determined by the local laboratory.
6. Participants must have at least 2 of the following risk factors:
7. 1. Age 65 or older
   2. Diabetes mellitus
   3. History of a prior MI (other than index ACS event)
   4. Multivessel CAD (Note: this may be a history of multivessel CAD or a history of single vessel CAD with the index ACS event being in a different coronary artery, establishing multivessel CAD.)
   5. History of CABG surgery prior to index ACS event
   6. History of PAD or cerebrovascular disease (eg., carotid atherosclerosis, intracranial artery stenosis. Please note that participants with a history of TIA or stroke are excluded from enrollment.)
   7. Conservative management (i.e., no PCI or CABG after index ACS event)
   8. Any one or more of the following high-risk angiographic features
   9. Total stent length of >30 mm
   10. Thrombotic target lesion
   11. Bifurcation lesion treated with more than one stent
   12. Calcified target lesion treated with atherectomy
   13. Treatment of obstructive left main or proximal left anterior descending artery for index ACS (or clinical diagnosis of an anterior STEMI)

Principal Investigator

Saihari Sadanandan, MD.

CONTACT US

Allis Delafield, BS, RN.

Research Administrator

• Phone Number: (813) 232-0339
• [email protected]

Protocol Title

TARGET BP-1: A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System Kit, in Subjects with Hypertension

Trial Purpose and Description

This is a Phase 3, prospective, randomized, blinded, sham procedure-controlled, multicenter trial to assess the efficacy and safety of renal denervation by alcohol-mediated neurolysis using the Peregrine system. Subjects with uncontrolled hypertension, who are taking 2, 3, 4, or 5 antihypertensive medications at enrollment will be recruited.

Inclusion Criteria

1. Male or female subject, aged ≥18 and ≤80 years at time of enrollment.
2. Subject is taking 2-5 antihypertensive medications (labeled for hypertension) at time of enrollment and is willing to adhere to a stable (no change) medication regimen during the 4-week run-in period and 3 months post-procedure. Antihypertensive medications must be as follows:

• Two of the antihypertensive medications must be at least 50% of their maximally labelled dose prior to the planned procedure.
• In subjects on 2 medications, one should be an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) except where subjects have documented intolerance to each of these drug classes.

Principal Investigator

Saihari Sadanandan, MD.

CONTACT US

Allis Delafield, BS, RN.

Research Administrator

• Phone Number: (813) 232-0339
• [email protected]