Interventions for Peripheral Arterial Disease
(XLPAD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of different treatments for peripheral arterial disease (PAD), a condition where leg arteries narrow. It compares the outcomes of using stents (tiny tubes that keep arteries open) with other non-stent therapies. The study will monitor whether these treatments improve symptoms and overall health, such as walking ability, over a year. Suitable participants have undergone a procedure to open leg arteries but not in the pelvic area and have not experienced a failed attempt or surgery for the condition. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. Treatment decisions are up to your care team, so it's best to discuss this with them.
What prior data suggests that these stent and non-stent based therapies are safe for PAD patients?
Research has shown that treatments without stents can be safe for some patients. For instance, one study found that avoiding stents in patients with certain heart conditions did not worsen outcomes if there was no severe blockage. Another study found that balloon angioplasty, which uses a small balloon to open blood vessels, was successful and resulted in few major limb problems a year later.
Different types of stents have also been researched. One study found that polymer-permanent everolimus stents have a lower risk of complications compared to others. Generally, many stents are considered safe and well-tolerated, though risks such as possible blood vessel issues after the procedure exist.
Both treatment options have been studied for safety with generally positive results, but each has its own considerations.12345Why are researchers excited about this trial?
Researchers are excited about the treatments for Peripheral Arterial Disease (PAD) in this trial because they explore both non-stent and stent-based therapies, offering a broader range of options compared to traditional stenting alone. Non-stent based therapies could offer less invasive solutions, potentially reducing recovery time and complications. Meanwhile, advancements in stent technology aim to improve durability and flexibility, which might lead to better long-term outcomes and fewer repeat procedures. These innovations could significantly enhance the quality of life for individuals with PAD, making them promising areas of study.
What evidence suggests that this trial's treatments could be effective for PAD?
Research has shown that treatments using stents for conditions like peripheral artery disease (PAD) can be very effective. Patients who received stents experienced fewer heart-related problems, such as heart attacks. Balloon angioplasty also works well, showing high initial success and similar rates of serious leg issues after one year compared to stents. Both treatments improve symptoms and help patients walk farther. These findings suggest that both stent-based and non-stent-based therapies could effectively manage PAD.36789
Who Is on the Research Team?
Subhash Banerjee, MD
Principal Investigator
Baylor Research Institute
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients undergo endovascular intervention with stent or non-stent based therapies
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Non-stent based therapies
- Stent-based therapies
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor Research Institute
Lead Sponsor
University of Texas Southwestern Medical Center
Lead Sponsor
Boston Scientific Corporation
Industry Sponsor
Michael F. Mahoney
Boston Scientific Corporation
Chief Executive Officer since 2016
MBA from Wake Forest University, BBA in Finance from the University of Iowa
Kenneth Stein
Boston Scientific Corporation
Chief Medical Officer since 2020
MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology