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Device

DCB Angioplasty with Paclitaxel for Ischemia

N/A
Waitlist Available
Led By Rabih A Chaer, MD
Research Sponsored by Rabih A. Chaer
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 3, 6, 12 months
Awards & highlights

Study Summary

This trial is important because it will help to establish whether or not DCB is safe and effective for treating femoropopliteal occlusive disease in CLI patients who also have tissue loss.

Who is the study for?
This trial is for patients with critical limb ischemia (CLI) and tissue loss who need treatment for blocked arteries in the leg. They must understand the study, agree to participate, and women of childbearing age must not be pregnant and use birth control. Excluded are those with weakened immune systems, aneurysms in target vessels, acute thrombus or allergy to Paclitaxel.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of drug-coated balloons (DCBs), specifically Medtronic DCB and Bard DCB using paclitaxel during angioplasty on femoropopliteal occlusive disease in CLI patients. It aims to address concerns raised by previous studies about this approach.See study design
What are the potential side effects?
Possible side effects include reactions related to paclitaxel such as pain at the site of blockage release, bleeding or bruising where catheters are inserted, potential artery damage, irregular heartbeats or allergic reactions to the drug.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12 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
Amputation
Wound Healing
Secondary outcome measures
Primary Patency ( determine if vessel remains open)
Rate of severe stenosis (narrowing) and reinterventions

Trial Design

1Treatment groups
Experimental Treatment
Group I: Critical Limb Ischemia (CLI) and Tissue LossExperimental Treatment2 Interventions
Paclitaxel® coated balloons will be used for patients identified with Critical Limb Ischemia (CLI) and Tissue Loss. Patients with CLI will receive either Angiogram, Medtronic DCB (paclitaxel)/stent or Angiogram, Bard DCB (paclitaxel)/stent

Find a Location

Who is running the clinical trial?

Rabih A. ChaerLead Sponsor
1 Previous Clinical Trials
66 Total Patients Enrolled
Rabih A Chaer, MDPrincipal InvestigatorUniversity of Pittsburgh

Media Library

Bard DCB (paclitaxel)/stent (Device) Clinical Trial Eligibility Overview. Trial Name: NCT02758847 — N/A
Ischemia Research Study Groups: Critical Limb Ischemia (CLI) and Tissue Loss
Ischemia Clinical Trial 2023: Bard DCB (paclitaxel)/stent Highlights & Side Effects. Trial Name: NCT02758847 — N/A
Bard DCB (paclitaxel)/stent (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02758847 — N/A

Frequently Asked Questions

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

Is my eligibility sufficient to partake in this experiment?

"A necessary criteria for participation in this experiment is having a diagnosis of ischemia and being between 40 to 95 years old. At the moment, 50 individuals are needed to join the trial."

Answered by AI

Are there any patient enrollment opportunities for this trial that are still available?

"According to the info posted on clinicaltrials.gov, this experiment is not actively seeking patients at present--the trial was initially shared in September 2016 and last modified on June 8th 2022. While no longer recruiting, there are currently 405 other trials that require participants."

Answered by AI

Is this clinical trial open to participants younger than 70 years old?

"This medical experiment is targeting individuals aged 40 to 95 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty
Rabih A. Chaer 2016. "Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02758847.
~6 spots leftby Apr 2025
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