Cocoa, FLNCT06492733Now EnrollingIRB Ready

Chronic Total Occlusion of Artery of the Extremities Clinical Trial in Cocoa, FL

Access cutting-edge chronic total occlusion of artery of the extremities treatment through this clinical trial at a research site in Cocoa. Study-provided care at no cost to qualified participants.

Sponsored by Versono Medical Ltd

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Expert Care in Cocoa

Access chronic total occlusion of artery of the extremities specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related chronic total occlusion of artery of the extremities treatment provided free

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Check if you qualify for this chronic total occlusion of artery of the extremities clinical trial in Cocoa, FL

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Why Participate?

  • No-Cost Study Care

  • Local to Cocoa

    Convenient for FL 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 Cocoa site if eligible
  4. 4Begin participation

About This Chronic Total Occlusion of Artery of the Extremities Study in Cocoa

This study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions (CTOs)

Sponsor: Versono Medical Ltd

Who Can Participate

Inclusion Criteria

Subjects who meet all the following criteria are eligible for this clinical investigation:
The patient signed and dated an Informed Consent Form.
Aged between 18 years and 85 years (inclusive).
Severe claudication assessed as Rutherford category 3 or CLTI assessed as Rutherford category 4 or 5 LEAD. Angiographic Inclusion Criteria Unless otherwise specified, the Investigator performing the procedure bases angiographic inclusion on the visual determination of qualification imaging taken at the time of the procedure. Subject must meet ALL the following angiographic inclusion criteria:
Angiographic confirmation at the time of the procedure of a de novo CTO below the origin of the superficial femoral artery (SFA) including above the knee or below the knee. (Note: Multilevel CTOs are included as long as the total length from the beginning of the most proximal total occlusion to the end of the most distal total occlusion is less than 40 cm.)
100% stenosis by a visual estimate of angiography at the time of procedure.
For below-the-knee CTOs, the target limb shall have at least one patent (\<50% stenosis) run-off vessel confirmed by angiography or magnetic resonance angiography at the time of the procedure.

Exclusion Criteria

Subjects who meet any of the following criteria are not eligible for this clinical investigation:
Life expectancy of less than 12 months.
Females who are pregnant or lactating (urine test for women of childbearing age).
Myocardial infarction or stroke in two months prior to the index procedure.
Known, unstable coronary artery disease or other, uncontrolled comorbidity.
Any known haemorrhagic or coagulation deficiency.
Known sensitivity to nickel, titanium, or their alloys.
Evidence of active infection, including but not limited to the target limb.
Current use of cocaine or other substances of abuse.
Patients who have received any thrombolytic therapy in the last two weeks.
History of severe allergy or contraindication, to contrast medium or other medications used during or after endovascular therapy.
Subject participating in another study involving an investigational drug or device.
Patient has surgery or vascular intervention planned within 30 days of the index procedure.
Patient has had a previous peripheral bypass that includes the target vessel.
Patient has had a previous intervention in the target CTO (angioplasty, stenting) including previous attempt at time of index procedure.
Patient tests positive for coronavirus disease (COVID-2019), as per site standard practice.
Estimated Glomerular Filtration Rate (eGFR) of less than 30 ml/min or creatine level \>2.5mg/ml.
Platelet count \< 50,000/μL. Angiographic Exclusion Criteria Unless otherwise specified, the Investigator performing the procedure bases angiographic exclusion on a visual determination of qualification imaging taken at the time of the procedure. Subject is excluded if ANY of the following angiographic exclusion criteria is met:
For below-the-knee CTOs, a target limb without at least one patent (\<50% stenosis) run-off vessel confirmed by angiography or magnetic resonance angiography at the time of the procedure.
Has an acute or sub-acute intraluminal thrombus within the target vessel.
Aneurysm distal to puncture access site at least twice the reference vessel diameter, located in the index vessel, abdominal aorta, iliac, or popliteal.
Has perforation, dissection, or other injury of the access site or index vessel requiring stenting or surgical intervention prior to attempting crossing of the target lesion with the FastWire System.

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 Cocoa?

Yes, this clinical trial (NCT06492733) has an active research site in Cocoa, FL 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.

Chronic Total Occlusion of Artery of the Extremities Treatment Options in Cocoa, FL

If you're searching for chronic total occlusion of artery of the extremities treatment options in Cocoa, FL, this clinical trial (NCT06492733) 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 Cocoa research site is actively enrolling participants for this clinical trial. You'll receive care from experienced chronic total occlusion of artery of the extremities 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 chronic total occlusion of artery of the extremities clinical trials near you to find additional studies recruiting in your area.

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