Is NCT06182397 recruiting in Tampa, FL?

Yes, NCT06182397 is currently recruiting participants at its Tampa, FL location. This arterial disease of legs clinical trial is actively enrolling qualified participants.

How do I join the arterial disease of legs clinical trial in Tampa?

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

Is participation in this Tampa 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.

Arterial Disease of Legs Clinical Trial in Tampa, FL

About This Arterial Disease of Legs Study in Tampa

This is a Pivotal, Prospective, randomized, two arm, placebo controlled, single-blind, multicenter trial that will be conducted at approximately 80 sites; approx. 50 sites with at least 50% of subjects will be recruited from USA and approx. 30 sites OUS - Europe, Australia and Asia. Each site will be capped at 30 maximum subjects recruited. The main goal of this clinical trial is to determine the effectiveness and safety of the sirolimus drug coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) for the treatment of below the knee arterial disease. Eligible subjects will be randomised in a 1:1 allocation ratio and stratified by recruiting countries. Each subject will be randomized to receive either: 1. MagicTouch PTA sirolimus coated balloon catheter (DCB) in addition to standard balloon angioplasty or 2. Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA).

Sponsor: Concept Medical Inc.

Who Can Participate

Inclusion Criteria

Age ≥ 21 years or minimum age (is allowed the inclusion of subjects \> 21 years OR adulthood minimum age (depending on the US state regulations)

Rutherford class 4 with documented WIFI score, not exceeding more than 30% of target patient population.

Rutherford class 5 to 6 in the target limb with documented WIFI score. Intraoperative Inclusion Criteria:

Single or sequential de novo or re-stenotic lesions (stenosis of \> 50% or occlusions) from 2 to 20cm in the proximal 200mm of below the knee arteries. Lesion is considered as one lesion if there is maximum of 30 mm gap between lesions at discretion of investigator. Below the knee arteries are Tibio-peroneal trunk, Peroneal bifurcation, anterior tibial artery, posterior tibial artery and peroneal artery. With documented Distal Run off a maximum of two tibial vessels can be treated in the index procedure. Inflow free from flow limiting lesions (\<50% stenosis) confirmed by duplex or angiography. Subjects with flow limiting inflow lesions (\>50% stenosis) can be included if lesion had been treated successfully (\<30% residual stenosis) before or during the index procedure.

Target vessel has angiographically documented unimpaired (\<50% stenosis) run off into a named Tibio-pedal artery (Peroneal, Anterior Tibial/ Dorsalis Pedis/ Posterior Tibial Artery)

Exclusion Criteria

Comorbid conditions limiting life expectancy ≤ 1 year

Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet

Subject is lactating, pregnant or planning to become pregnant during the course of the study

Subject with extensive tissue loss salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputation. This includes subjects with:

Osteomyelitis including and/or proximal to the metatarsal head

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

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

Full thickness 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 would require flap coverage or complex wound management for large soft tissue defect

Full thickness wounds on the dorsum of the foot with exposed tendon or bone

Prior bypass surgery of target vessel

Planned amputation of the target limb (major)

Previously implanted stent in the target lesion

Vulnerable or protected adults

Bleeding diathesis or another disorder (i.e. gastrointestinal ulceration,etc) which would prevent the use of mandated antiplatelet agents

Known allergy to sirolimus

Subjects with severe (Stage 4) renal disease, defined eGFR \< 30. Intraoperative exclusion criteria:

Failure to successfully cross the target lesion with a guide wire

Target vessel has lesions extending beyond the ankle joint

Failure to obtain \<30% residual stenosis prior to randomization

Lesions requiring treatment through retrograde access . Retrograde wire crossing is allowed but treatment must be performed from the antegrade approach.

Use of commercially available DCBs, bare metal stents, drug eluting stents, specialty balloons or atherectomy devices at the target lesions. (Non-compliant balloons are not considered specialty balloons). For Inflow and non-target lesions all the approved devices are allowed.

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 Tampa?

Yes, this clinical trial (NCT06182397) has an active research site in Tampa, 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.

Arterial Disease of Legs Treatment Options in Tampa, FL

If you're searching for arterial disease of legs treatment options in Tampa, FL, this clinical trial (NCT06182397) 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 Tampa research site is actively enrolling participants for this clinical trial. You'll receive care from experienced arterial disease of legs 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 arterial disease of legs clinical trials near you to find additional studies recruiting in your area.

Arterial Disease of Legs Clinical Trial in Tampa, FL

Expert Care in Tampa

IRB Approved

No-Cost Care

Apply for This Tampa Location

Why Participate?

Simple Process