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Drug Eluting Balloon

SELUTION SLR™ DEB 014 for Peripheral Arterial Disease

N/A

Recruiting

Research Sponsored by MedAlliance, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 6, 12, 24, and 36 months

Awards & highlights

Study Summary

This trial is trying to show that a specific type of balloon called SELUTION SLR™ DEB 014 works better and is just as safe as a regular balloon in treating peripheral arterial disease in patients

Who is the study for?

This trial is for adults with chronic limb-threatening ischemia in the lower limbs, who have a life expectancy of at least one year and can follow study procedures. They must not be pregnant or breastfeeding and agree to use contraception if applicable. The disease should be classified as Rutherford category 4-6, affecting arteries below the knee but above the ankle without severe blockages elsewhere.Check my eligibility

What is being tested?

The SELUTION SLR™ DEB 014 drug-coated balloon is being tested against plain balloon angioplasty for treating peripheral arterial disease in arteries below the knee. The goal is to see if it's more effective and just as safe.See study design

What are the potential side effects?

Potential side effects may include pain at the intervention site, bleeding, infection, blood vessel damage, allergic reactions to materials used during treatment, or complications leading to further surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 6, 12, 24, and 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 6, 12, 24, and 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 6, 12, 24, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Efficacy Endpoint

Primary Safety Endpoint

Secondary outcome measures

ABI/TBI/Toe Pressure

All-cause mortality

Amputation-free survival

+17 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SELUTION SLR™ DEB 014Experimental Treatment1 Intervention

Group II: Plain (Uncoated) Balloon Angioplasty (PTA)Active Control1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

MedAlliance, LLCLead Sponsor

1 Previous Clinical Trials

300 Total Patients Enrolled

1 Trials studying Peripheral Arterial Disease

300 Patients Enrolled for Peripheral Arterial Disease

NAMSAOTHER

45 Previous Clinical Trials

16,547 Total Patients Enrolled

3 Trials studying Peripheral Arterial Disease

606 Patients Enrolled for Peripheral Arterial Disease

M.A. Med Alliance S.A.Lead Sponsor

8 Previous Clinical Trials

5,865 Total Patients Enrolled

4 Trials studying Peripheral Arterial Disease

1,127 Patients Enrolled for Peripheral Arterial Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the trial currently accepting new participants?

"As per the details available on clinicaltrials.gov, recruitment for this trial is ongoing. The study was first posted on May 19th, 2022 and last modified on March 12th, 2024."

Answered by AI

Are a substantial number of medical facilities in North America involved in conducting this research?

"Currently, this medical research endeavor is actively enrolling participants from a total of 37 locations. Notable cities where these sites are based include Paris, Thornton, and Miami among many others. Opting for the site nearest to you is recommended to reduce travel obligations should you decide to participate."

Answered by AI

What is the current number of individuals receiving medical care as part of this research project?

"Yes, the details on clinicaltrials.gov confirm that patient recruitment for this research is ongoing. The study was first made available on May 19th, 2022 and underwent its latest update on March 12th, 2024. Enrollment aims to reach a total of 376 participants distributed across 37 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SELUTION4BTK Trial

2022. "SELUTION4BTK Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05055297.

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