Des Moines, IANCT06182397Now EnrollingIRB Ready

Arterial Disease of Legs Clinical Trial in Des Moines, IA

Access cutting-edge arterial disease of legs treatment through this clinical trial at a research site in Des Moines. Study-provided care at no cost to qualified participants.

Sponsored by Concept Medical Inc.

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Expert Care in Des Moines

Access arterial disease of legs specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related arterial disease of legs treatment provided free

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Check if you qualify for this arterial disease of legs clinical trial in Des Moines, IA

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Why Participate?

  • No-Cost Study Care

  • Local to Des Moines

    Convenient for IA 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 Des Moines site if eligible
  4. 4Begin participation

About This Arterial Disease of Legs Study in Des Moines

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 Des Moines?

Yes, this clinical trial (NCT06182397) has an active research site in Des Moines, IA 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 Des Moines, IA

If you're searching for arterial disease of legs treatment options in Des Moines, IA, 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 Des Moines 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.

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