Peripheral Arterial Disease Trial, Recruiting NCT06573437 Sponsor: Braile Biomedica Ind. Com. e Repr. Ltda. Condition: Peripheral Arterial Disease
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Peripheral Arterial Disease Trial, Recruiting

NCT06573437
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older
  • People with a specific type of aortoiliac artery blockage or narrowing (classified under a system called TASC-II as modified class A, B, C, or D — confirm with trial site)
  • People with a Rutherford score of 2 to 5, which is a scale used to measure how severely reduced blood flow is affecting the legs (confirm with trial site)
  • People whose blood vessel access point is physically compatible with the medical device used in this trial
  • People whose condition fits within the instructions for how the device is meant to be used
  • People who are able to attend all required follow-up appointments for the full duration of the study
  • People who have been fully informed about the study, agree to its terms, and have signed a consent form

Who may not be able to join:

  • People with a known allergy or sensitivity to heparin, contrast dye, or the materials used in stents
  • People with a blood disorder or disease affecting the blood (confirm with trial site)
  • People who are pregnant or breastfeeding
  • People currently taking part in another clinical trial involving an investigational drug or medical device
  • People currently receiving chemotherapy or radiation therapy
  • People who already have a stent or graft in the leg being treated
  • People who had angioplasty or bypass surgery in the 30 days before joining the study
  • People with a life expectancy of less than 12 months
  • People who are unable to take a two-drug blood-thinning treatment known as dual antiplatelet therapy (DAPT)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Fabio Cypreste Oliveira, Hospital Santa Helena

Phone: +55 (17) 2136-7005

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Braile Biomedica Ind. Com. e Repr. Ltda.
Registry
ClinicalTrials.gov
Start date
21 June 2024
Est. completion
1 August 2025

Where this trial is recruiting

🇧🇷 Brazil

Primary endpoints

Incidence of Device-Related Serious Adverse Events (Device Safety); Number of Patients with Technical Success (Device Performance); Number of Patients Without Rupture or Dissection of the Treated Vessel (Combined Safety and Performance Outcome)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov