Phase 3 Peripheral Arterial Disease Trial, Recruiting (NCT06553443)

Phase 3 Peripheral Arterial Disease Trial, Recruiting NCT06553443 Sponsor: Singapore General Hospital Condition: Peripheral Arterial Disease

Printed from Voxsanity (voxsanity.com.au) — NCT06553443 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Peripheral Arterial Disease

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:

You have an arteriovenous fistula (AVF — a surgically created connection between an artery and vein used for dialysis) that is not working well, with at least one narrowing causing problems with blood flow or dialysis performance (both new and returning narrowings are accepted).
Your AVF has been successfully used for dialysis for at least 1 month.
After a balloon procedure to open the narrowing, less than 30% blockage remains.
You are 21 years old or older.
You have been given information about the trial and have agreed to take part.

Who may not be able to join:

Your AVF has a blood clot blocking it completely.
You have a significant narrowing in the large veins near the centre of your body (such as in the chest) that is causing serious blood flow problems.
The narrowing in your fistula is too large to be treated with the available sizes of the special drug-coated balloon used in this trial (up to 8mm wide).
You cannot take blood-thinning or antiplatelet medications (medicines that help prevent clots).
You have a serious blood clotting disorder or very low platelet levels that cannot be safely managed around the time of the procedure.
You have an allergy or medical reason that prevents you from receiving paclitaxel (the drug used on the balloon in this trial).
You have an active infection at the site where the needle would be inserted.
You are currently breastfeeding, pregnant, or planning to become pregnant during the study.
You have other medical conditions that, in the doctor's opinion, may make it difficult for you to follow the study requirements (confirm with trial site).
You are currently taking part in another clinical trial involving a drug, biological treatment, or medical device that could affect your dialysis access, or you have previously taken part in this same study.

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 27 July 2026

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 6222 3322

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.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT06553443

Sponsor: Singapore General Hospital

Phase: Phase 3

Status: Recruiting

Condition: Peripheral Arterial Disease

Trial contact: 6222 3322

More information: https://clinicaltrials.gov/study/NCT06553443

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You have an arteriovenous fistula (AVF — a surgically created connection between an artery and vein used for dialysis) that is not working well, with at least one narrowing causing problems with blood flow or dialysis performance (both new and returning narrowings are accepted).
Your AVF has been successfully used for dialysis for at least 1 month.
After a balloon procedure to open the narrowing, less than 30% blockage remains.
You are 21 years old or older.
You have been given information about the trial and have agreed to take part.

Who may not be able to join:

Your AVF has a blood clot blocking it completely.
You have a significant narrowing in the large veins near the centre of your body (such as in the chest) that is causing serious blood flow problems.
The narrowing in your fistula is too large to be treated with the available sizes of the special drug-coated balloon used in this trial (up to 8mm wide).
You cannot take blood-thinning or antiplatelet medications (medicines that help prevent clots).
You have a serious blood clotting disorder or very low platelet levels that cannot be safely managed around the time of the procedure.
You have an allergy or medical reason that prevents you from receiving paclitaxel (the drug used on the balloon in this trial).
You have an active infection at the site where the needle would be inserted.
You are currently breastfeeding, pregnant, or planning to become pregnant during the study.
You have other medical conditions that, in the doctor's opinion, may make it difficult for you to follow the study requirements (confirm with trial site).
You are currently taking part in another clinical trial involving a drug, biological treatment, or medical device that could affect your dialysis access, or you have previously taken part in this same study.

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

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 27 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 3

Sponsor

Singapore General Hospital

Registry

ClinicalTrials.gov

Start date

4 January 2024

Est. completion

31 December 2025

Where this trial is recruiting

🇸🇬 Singapore

Primary endpoints

Access circuit primary patency

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: 27 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