Lafayette, LANCT05916950Now EnrollingIRB Ready

Peripheral Artery Disease Clinical Trial in Lafayette, LA

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

Sponsored by Philips Clinical & Medical Affairs Global

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Expert Care in Lafayette

Access peripheral artery disease specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related peripheral artery disease treatment provided free

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Check if you qualify for this peripheral artery disease clinical trial in Lafayette, LA

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Why Participate?

  • No-Cost Study Care

  • Local to Lafayette

    Convenient for LA 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 Lafayette site if eligible
  4. 4Begin participation

About This Peripheral Artery Disease Study in Lafayette

The goal of this clinical trial is to test the Thor system in adult (≥ 18 year old) patients with de novo (new, never treated) calcified lesions in infrainguinal (leg) arteries (peripheral artery disease or PAD). The main question\[s\] it aims to answer are: * Is the Thor system safe in treating these lesions * Does the Thor system work to treat these lesions Participants will: * Receive treatment with the Thor system * Have follow-up visits at Discharge, 30 days, 6 months, and 12 months

Sponsor: Philips Clinical & Medical Affairs Global

Who Can Participate

Inclusion Criteria

Patient age is ≥18 years
Patient agrees to participate and to comply with the protocol by signing an IRB approved patient consent form
Patient is able to walk unassisted or with non-motorized assistive devices
Patient has PAD with documented Rutherford Class 2-4 of the target limb
Anticipated life expectancy \>12 months, in the opinion of the investigator at the time of enrollment. Angiographic Inclusion Criteria:
Patient has de novo atherosclerotic disease of the native SFA and/or the popliteal arteries
Target lesion has ≥70% diameter stenosis by investigator via visual assessment
Target lesion length ≤150mm. Total treatment zone may not exceed 150mm, and may include one or more lesions.
Chronic total occlusion lesion length is \<100mm of the total ≤150mm target lesion
Minimum reference vessel diameter (RVD) 4.0mm by visual estimate
Target lesion crossed and intraluminal guidewire placement confirmed; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations
At least one patent tibial vessel (defined as \<50% stenosis) with runoff to the foot
Target lesion has moderate to severe calcification graded using the Peripheral Academic Research Consortium (PARC) criteria

Exclusion Criteria

Patient has active infection requiring antibiotic therapy
Stenting planned within the target lesion
Known positive for COVID-19 within the last 2 weeks and actively symptomatic
Pregnant (positive pregnancy test) or currently breast feeding
Evidence of Acute Limb Ischemia in the target limb within 7 days prior to procedure
Cerebrovascular accident (CVA) \<60 days prior to procedure
Myocardial infarction \<60 days prior to procedure
History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to baseline screening
Known contraindication to aspirin, or antiplatelet/anti-coagulant therapies required for procedure/follow-up
Known allergy to contrast media that cannot adequately be premedicated prior to study procedure
History of Thrombophilia, Heparin-induced Thrombocytopenia (HIT), or Heparin-induced Thrombotic Thrombocytopenia Syndrome (HITTS)
Serum creatinine ≥2.5mg/dL (unless dialysis-dependent) tested within 30 days prior to procedure
Planned lower limb major amputation (above the ankle)
Other surgical or endovascular procedure in the target limb that occurred within 14 days prior to index procedure or is planned on target limb for within 30 days following index procedure, with the exception of diagnostic angiography
Currently participating in any investigational device or drug clinical trial that, in the opinion of the investigator, will interfere with the conduct of the current study
The use of specialty balloons, re-entry or additional atherectomy devices is required for treatment of the target lesion. Angiographic Exclusion Criteria:
Subject has significant stenosis (\>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g. iliac or common femoral) not successfully treated.
Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to the target site at the time of the index procedure.

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 Lafayette?

Yes, this clinical trial (NCT05916950) has an active research site in Lafayette, LA 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 Artery Disease Treatment Options in Lafayette, LA

If you're searching for peripheral artery disease treatment options in Lafayette, LA, this clinical trial (NCT05916950) 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 Lafayette research site is actively enrolling participants for this clinical trial. You'll receive care from experienced peripheral artery 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 artery disease clinical trials near you to find additional studies recruiting in your area.

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