Charleston, WVNCT07258290Now EnrollingIRB Ready

Coronary Disease Clinical Trial in Charleston, WV

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

Sponsored by Teleflex

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Expert Care in Charleston

Access coronary disease specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related coronary disease treatment provided free

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Check if you qualify for this coronary disease clinical trial in Charleston, WV

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Why Participate?

  • No-Cost Study Care

  • Local to Charleston

    Convenient for WV 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 Charleston site if eligible
  4. 4Begin participation

About This Coronary Disease Study in Charleston

The objective of this study is to assess the safety and efficacy of the Freesolve resorbable magnesium scaffold (RMS) in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to the Xience coronary drug-eluting stent (DES) system

Sponsor: Teleflex

Who Can Participate

Inclusion Criteria

Subject is ≥ 18 years and ≤ 80 years of age
Subject has provided written informed consent as approved by the Ethics Committee / Institutional Review Board (IRB) of the respective clinical site prior to the study related procedures
Subject is eligible for PCI according to the applicable guidelines
Subject is an acceptable candidate for coronary artery bypass surgery
Subjects with stable or unstable angina pectoris, documented silent ischemia/abnormal physiologic testing or hemodynamically stable non-ST elevation myocardial infarction (NSTEMI) patients without angiographic evidence of thrombus at target lesion Note: STEMI patients may be eligible for the study for treatment of selected non-culprit lesions, if:
Subject and target lesion(s) meet all inclusion and no

Exclusion Criteria

and consent occurs at least ≥ 72 hours after successful treatment of the culprit lesion(s) \[lesion(s) causing the acute STEMI\];
Subject is hemodynamically stable with documented declining cardiac biomarkers;
Target lesion(s) to be treated are not located in the culprit vessel(s) and are not culprit lesion(s)
Subject is eligible for Dual Antiplatelet Therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine
Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to randomization)
Subject is willing and able to comply with protocol requirements, including completion of study visits for the duration of the study Angiographic Inclusion Criteria:
Subjects with a maximum of two single de novo target lesions each in separate native coronary arteries
Target vessel must have a reference diameter between 2.5-4.2 mm by operator visual estimation, which may be assisted by Quantitative Coronary Angiography (QCA) / Intravascular Ultrasound (IVUS) / Optical Coherence Tomography (OCT)
Target lesion(s) must be ≤ 36 mm in length by operator visual estimation, which may be assisted by QCA / IVUS / OCT, (or \< 20 mm for target lesion(s) to be treated with a study device \< 3.0 mm in diameter) and must be amenable to treatment with a single study device
Target lesion stenosis ≥ 50% and \< 100% by operator visual estimation, which may be assisted by QCA / IVUS / OCT. Target lesion stenosis \< 70% by visual estimation, should have clinical justification for treatment as per local standards.
Target lesion must have a Thrombolysis in Myocardial Infarction (TIMI) flow ≥ 1 Clinical Exclusion Criteria:
Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study
Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with STEMI \< 72 hours prior to the index procedure Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment
Subject has undergone prior PCI within the target vessel during the last 12 months prior to the index procedure or prior PCI within a non-target vessel \< 72 hours prior to the index procedure
Subject is on dialysis or has impaired renal function (serum creatinine \> 2.5 mg/dL or 221 µmol/L, determined within 7 days prior to the index procedure)
Subject has a known allergy to contrast medium that cannot be adequately premedicated, or any known allergy to aspirin, P2Y12 inhibitors, both heparin and bivalirudin, sirolimus, everolimus (or similar limus drugs), poly L-lactide, the scaffold material (magnesium, aluminum, tantalum), or Xience stent material (cobalt, chromium, tungsten, nickel, methacrylic polymer, and fluoropolymer)
Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are permitted) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is permitted)
Life expectancy less than 1 year
Planned surgery or dental surgical procedure within 6 months after index procedure, unless DAPT can be maintained
In the investigator's opinion subject will not be able to comply with the follow-up requirements
Subjects under oral anticoagulation therapy (OAC) prior to index procedure unless DAPT + OAC (i.e., triple therapy) can be maintained for a minimum of 1 month
Subject has had a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure
Subject with active bleeding disorder, active coagulopathy, or any other reason, who is ineligible for DAPT
Subject is currently participating or plans to participate in another study with an investigational device or an investigational drug
Subject has known severe aortic or mitral valve stenosis/insufficiency or has previously undergone transcatheter aortic valve replacement (TAVR) Angiographic Exclusion Criteria:
Target vessel has been previously treated and the target lesion is within 5 mm proximal or distal to the previously treated lesion
Left main coronary artery disease
Target lesion is totally occluded (100% stenosis)
Thrombus in target vessel
Future planned staged PCI either in target or non-target vessel
Ostial target lesion within the left anterior descending (LAD), left circumflex (LCX), or right coronary artery (RCA) (within 5.0 mm of vessel origin)
Target lesion involves a side branch ≥ 2.0 mm in diameter that requires a two-device strategy after pre-dilatation
Target lesion is located in or supplied by an arterial or venous bypass graft
Target lesion with excessive tortuosity proximal to or within the lesion based on visual estimation or heavily calcified target lesion which cannot be adequately pre-dilated by a non-compliant and/or cutting/scoring balloon as described in angiographic exclusion criteria 10
Target lesion requires treatment with a device other than the non-compliant balloon and/or cutting/scoring balloon prior to scaffold/stent placement (including but not limited to atherectomy devices, intravascular lithotripsy, drug-coated balloons, etc.)
Target vessel was treated with brachytherapy any time prior to the index procedure.
Unsuccessful pre-dilatation, defined as residual stenosis \> 20% (by visual estimation) and/or angiographic complications (e.g., distal embolization, side branch closure, flow-limiting dissections)

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 Charleston?

Yes, this clinical trial (NCT07258290) has an active research site in Charleston, WV 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 Disease Treatment Options in Charleston, WV

If you're searching for coronary disease treatment options in Charleston, WV, this clinical trial (NCT07258290) 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 Charleston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced coronary 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 disease clinical trials near you to find additional studies recruiting in your area.

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