Roslyn, NYNCT07045194Now EnrollingIRB Ready

Coronary Artery Disease Clinical Trial in Roslyn, NY

Access cutting-edge coronary artery disease treatment through this clinical trial at a research site in Roslyn. Study-provided care at no cost to qualified participants.

Sponsored by Orchestra BioMed, Inc

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Expert Care in Roslyn

Access coronary artery disease specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related coronary artery disease treatment provided free

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Check if you qualify for this coronary artery disease clinical trial in Roslyn, NY

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Why Participate?

  • No-Cost Study Care

  • Local to Roslyn

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Roslyn site if eligible
  4. 4Begin participation

About This Coronary Artery Disease Study in Roslyn

A prospective, multi-center, single-blind, randomized (1:1), non-inferiority study comparing clinical outcomes of the Virtue® Sirolimus AngioInfusion™ Balloon (SAB) to the AGENT™ Paclitaxel Drug-Coated Balloon (DCB) in the treatment of coronary artery in-stent restenosis (ISR).

Sponsor: Orchestra BioMed, Inc

Who Can Participate

Inclusion Criteria

In-stent restenosis (one or two stent layers) in a lesion previously treated with drug- eluting (DES) or bare metal stents (BMS) in a native coronary artery.
The target lesion is in a vessel with a reference vessel diameter ≥ 2.0 mm and ≤ 4.0 mm by visual assessment.
The subject has only one critical ISR lesion.
The subject may have one other critical lesion in a non-target vessel that must be treated before the Target Lesion (TL).
Target lesion length must be ≤ 26 mm and must be completely coverable by only one Virtue® or AGENT™ balloon. The balloon can extend up to 5 mm proximal or distal beyond the edge of the target stented length.
The target lesion must have one of the following:
Visually estimated stenosis of ≥ 70% and \<100% diameter stenosis, OR
Visually estimated stenosis ≥ 50% and \< 70% with one of the following:
abnormal fractional flow reserve (FFR) including Angio based FFR ≤ 0.80, or;
abnormal instantaneous wave-free ratio (iFR) or resting full-cycle ratio (RFR) ≤ 0.89, or;
abnormal stress or imaging stress test, or;
ischemic symptoms referable to the target lesion
Involved in a NSTEMI or Acute Coronary Syndrome (ACS) event with decreasing enzymes
Target lesion must be successfully pre-treated according to standard of care with an achieved residual stenosis of ≤ 30% by visual estimate with TIMI grade flow of 3 prior to randomization.

Exclusion Criteria

Subject has a left ventricular ejection fraction \< 30% within 6 months.
Subject was treated by PCI or another coronary intervention within the last 30 days.
Planned PCI or CABG after the index procedure.
Subjects with STEMI \< 72 hours prior to index procedure and those with NSTEMI who have increasing biomarkers within 12 hours of the index procedure.
If single-layer ISR, any previous treatment (other than balloon angioplasty alone) of the target vessel for restenosis. If double-layer ISR, any treatment (other than balloon angioplasty alone) of the double-layer ISR restenosis.
Target lesion is located within a saphenous vein graft or an arterial graft.
Thrombus is present in the target vessel.
\> 50% stenosis of an additional lesion proximal or clinically significant distal (\>2.0mm RVD) to the target lesion.
A dissection in the target lesion requiring treatment with a stent post pre-dilatation.
The target ISR lesion has more than two layers of previously placed stents.
Subject has critical unprotected left main coronary artery disease.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Roslyn?

Yes, this clinical trial (NCT07045194) has an active research site in Roslyn, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Coronary Artery Disease Treatment Options in Roslyn, NY

If you're searching for coronary artery disease treatment options in Roslyn, NY, this clinical trial (NCT07045194) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Roslyn research site is actively enrolling participants for this clinical trial. You'll receive care from experienced coronary artery disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all coronary artery disease clinical trials near you to find additional studies recruiting in your area.

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