Is NCT06321575 recruiting in Fort Lauderdale, FL?

Yes, NCT06321575 is currently recruiting participants at its Fort Lauderdale, FL location. This peripheral arterial disease clinical trial is actively enrolling qualified participants.

Is participation in this Fort Lauderdale clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Peripheral Arterial Disease Clinical Trial in Fort Lauderdale, FL

Q: How do I join the peripheral arterial disease clinical trial in Fort Lauderdale?

To join this clinical trial in Fort Lauderdale, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Peripheral Arterial Disease Study in Fort Lauderdale

The objective of this study is to establish reasonable assurance of safety and effectiveness of the Golazo® Peripheral Atherectomy System when used as indicated in 159 subjects with symptomatic infrainguinal peripheral arterial disease (PAD) in up to 20 investigational sites in the U.S.

Sponsor: Avantec Vascular

Who Can Participate

Inclusion Criteria

Age ≥18 years

Candidate for atherectomy of the peripheral vasculature in the lower limbs

Life expectancy \>1 year in the opinion of the investigator

Resting ankle brachial index (ABI) ≤0.90, or ≤0.75 after exercise. Subjects with non-compressible arteries shall have a toe brachial index (TBI) assessment.

Target limb Rutherford clinical classification category 3 to 5

Suitable candidate for angiography and endovascular intervention in the opinion of the investigator

Willing and able to comply with the protocol-specified procedures and assessments

Informed consent granted Angiographic inclusion criteria:

Target lesion(s) defined as stenosis ≥70% by angiographic visual estimation

Total treated lesion length ≤20 cm by angiographic visual estimation

Target reference vessel diameter (RVD) ≥2.0 mm and ≤4.5 mm by angiographic visual estimation

Target limb will have a minimum of one patent (less than 50% stenosis) below the knee (BTK) vessel crossing the ankle, distal to any target lesion, providing perfusion to the foot at baseline General

Exclusion Criteria

Active infection in the target limb

History of an endovascular procedure or open vascular surgery on the target limb within the last 30 days

Planned surgical or interventional procedure within 30 days after the index procedure

Lesion in the contralateral limb requiring intervention during the index procedure or within next 30 days

Critical limb ischemia (CLI) with Rutherford clinical classification category 6

Significant acute or chronic kidney disease with a GFR \<30 and/or requiring dialysis

Acute myocardial infarction (non-ST-elevation myocardial infarction or ST-segment elevation myocardial infarction) or other uncontrolled comorbidity in the opinion of the investigator

Myocardial infarction (MI) or stroke within two months of baseline evaluation

Pregnant or lactating

Subject is participating in another clinical investigation of a device, drug, or procedure that has not completed the study treatment or that clinically interferes with the endpoints of this study (post-approval registries are allowed as long as the investigator determines there is no clinical interference with study endpoints)

Contraindication to antiplatelet, anticoagulant, or thrombolytic therapy

Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count \<125,000/microliter, known coagulopathy, or international normalized ratio (INR) \>1.5

Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately medicated

History of heparin-induced thrombocytopenia (HIT)

Any thrombolytic therapy within two weeks of enrollment

Target lesion(s) within a native vessel graft or synthetic graft

Significant stenosis or occlusion of inflow not successfully treated before the index procedure

Any evidence or history of intracranial or gastrointestinal bleeding or intracranial aneurysm

Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)

One or more of the following complications of the foot:

Osteomyelitis that extends to the metatarsal bones.

Gangrene involving the plantar skin of the forefoot, midfoot or heel

Deep ulcer or large shallow ulcer (\>3cm) involving the plantar skin of the forefoot, midfoot, or heel

Any heel ulcer with/without calcaneal involvement

Any wound with calcaneal bone involvement

Wounds that are deemed to be neuropathic or non-ischemic in nature

Wounds that require flap coverage or complete wound management for large soft tissue defect

Congestive heart failure with a NYHA functional classification of III or higher Angiographic exclusion criteria:

More than 2 lesions to be treated with the investigational device; lesions located within 3 mm may be considered a single tandem lesion

Clinical/angiographic complication (other than non-flow limiting dissections) attributed to a currently marketed device prior to introduction of the investigational device

In-stent restenosis within the target lesion(s)

Potentially unstable or flow-limiting dissection, type C or greater

Clinical/angiographic evidence of distal embolization

Inability to cross the proximal lesion vessel lumen with a guidewire (not subintimal)

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 Fort Lauderdale?

Yes, this clinical trial (NCT06321575) has an active research site in Fort Lauderdale, 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.

Peripheral Arterial Disease Treatment Options in Fort Lauderdale, FL

If you're searching for peripheral arterial disease treatment options in Fort Lauderdale, FL, this clinical trial (NCT06321575) 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 Fort Lauderdale research site is actively enrolling participants for this clinical trial. You'll receive care from experienced peripheral arterial 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 peripheral arterial disease clinical trials near you to find additional studies recruiting in your area.

Peripheral Arterial Disease Clinical Trial in Fort Lauderdale, FL

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