Explore Our Current Cardiovascular Clinical Trials at Advanced Heart and Vascular Institute of Hunterdon
We are actively enrolling participants in two leading-edge cardiovascular studies, with more coming soon! That aim to improve treatment for heart and vascular conditions. These trials offer access to promising therapies under the guidance of Dr. Espinoza and the research team, with all study-related care provided at no cost.
TRANSFORM Trial – Personalized Heart Disease Care
ClinicalTrials.gov ID NCT06112418
The TRANSFORM trial, sponsored by Cleerly Health, is a randomized, open-label study aiming to enroll 7,500 patients with pre-diabetes, type 2 diabetes, or metabolic syndrome and no symptoms of heart disease. The trial seeks to demonstrate that a personalized care strategy based on Cleerly’s AI-enabled coronary artery disease (CAD) staging system is more effective than traditional care based on cardiovascular risk factors for the primary prevention of cardiovascular events.
Key Details:
Study Type:
- Prospective, randomized, open blinded endpoint (PROBE), event-driven, pragmatic trial
Who Can Join?
- Adults aged ≥18 with pre-diabetes, type 2 diabetes, or metabolic syndrome and no known symptomatic cardiovascular disease
Who Can Not Join?
- Known history of symptomatic cardiovascular disease
Golazo® Peripheral Atherectomy System Study
ClinicalTrials.gov ID: NCT06321575
This trial evaluates the Golazo® system for the treatment of peripheral arterial disease (PAD). It is a non-randomized, open-label study investigating the device’s ability to safely remove plaque from arteries. Participants will receive cardiovascular assessments and care throughout the study period.
Key Points:
- Adults with diagnosed PAD may qualify (PAD should be a link to active conditions if I did it right)
- Conducted in-office
- Sponsored by Avantec Vascular
Who Can Join?
- Age ≥18 with PAD symptoms (Rutherford category 3–5)
- Objective ABI/TBI criteria and angiographic lesion specifics
- Must be a suitable candidate for angiography and endovascular intervention
Who Can Not Join?
- Significant kidney disease or recent cardiac events
- Target limb with active infection or recent interventions
- Complex foot wounds or contraindications to key therapies
PARAMOUNT-CAD Study
ClinicalTrials.gov ID: NCT06713239
The PARAMOUNT-CAD trial evaluates whether using AI-enabled cleerly CT plaque analysis leads to better diagnosis and treatment of coronary artery disease (CAD) in symptomatic patients.
Study Design:
- Randomized, open-label, prospective study
- Personalized plaque-based management vs. standard care
- Sponsored by Cleerly Inc.
Who Can Join?
- Adults 18+ with symptoms suggestive of CAD
- Referred for non-urgent diagnostic testing (e.g., stress test)
Who Cannot Join?
- Low LDL (<100 mg/dL)
- Prior invasive CAD testing or treatment
- History of heart attack, stents, or bypass surgery
- Heart function <40% or certain heart diseases
- Planned cardiovascular procedures or recent imaging
- Contraindications to CT angiography
Ready to Take the Next Step?
If you or a loved one is interested in learning more abut one of these trials or to see if you would be a good fit, please reach out
by the contact information below or by filling out a form. By joining a clinical study, you’ll receive advanced cardiovascular
monitoring and contribute to the future of heart health innovation.
Contact us today at 908-291-3405 or by email to either Erin Squindo esquindo@ahvi-nj.com or Alexis Bellafiore abellafiore@ahvi-nj.com to see if you’re eligible.