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Drug-Coated Balloon
Drug-Coated Balloon for Peripheral Artery Disease (TRANSCEND Trial)
N/A
Waitlist Available
Led By Marianne Brodmann, MD
Research Sponsored by SurModics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is ≥18 years.
Successful, uncomplicated (without use of a crossing device) wire crossing of target lesion. Successful crossing of the target lesion occurs when the tip of the guide wire is distal to the target lesion without the occurrence of flow-limiting dissection or perforation and is judged by visual inspection to be within the true lumen.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36months, 48 months, 60 months
Awards & highlights
TRANSCEND Trial Summary
This trial tests a new drug-coated balloon to treat peripheral artery disease. The goal is to show it is safe and effective.
Who is the study for?
Adults with symptomatic peripheral artery disease due to femoral/popliteal artery blockage. They must have a specific level of arterial disease severity, be able to follow the study plan, and not have had certain recent treatments or conditions that could interfere with the trial.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of SurVeil Drug-Coated Balloon (DCB) compared to Medtronic IN.PACT Admiral DCB in treating narrowed arteries in patients with peripheral artery disease.See study design
What are the potential side effects?
Potential side effects may include local reactions at the treatment site, bleeding complications due to antiplatelet therapy, possible allergic reactions to drug coatings or contrast media used during procedures.
TRANSCEND Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My procedure to cross the target lesion with a wire was successful without complications.
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My leg pain is moderate to severe, affecting my daily activities.
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My targeted lesion is located in a specific part of my upper leg.
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My cancer lesion is 180 mm or shorter in total length.
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My target lesion is severely narrowed, as seen in imaging.
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My heart blockage is less than 70% after initial treatment and can be treated with available tools.
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I have at least one clear artery to my ankle or foot without major narrowing.
TRANSCEND Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36months, 48 months, 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36months, 48 months, 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Lesion Patency Though 12 Months
Safety Composite of Freedom From Death, Amputation, and Target Vessel Revascularization (TVR)
Secondary outcome measures
Change in 6-Minute Walk Test (6MWT)
Change in Peripheral Artery Questionnaire (PAQ)
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class
+15 moreTRANSCEND Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Surmodics SurVeil DCBExperimental Treatment1 Intervention
Surmodics SurVeil Drug-Coated Balloon is an investigational device coated with paclitaxel.
Group II: Medtronic IN.PACT Admiral DCBActive Control1 Intervention
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
Find a Location
Who is running the clinical trial?
SurModics, Inc.Lead Sponsor
6 Previous Clinical Trials
631 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
548 Patients Enrolled for Peripheral Arterial Disease
Marianne Brodmann, MDPrincipal InvestigatorMedical University Graz, Department of Internal Medicine
8 Previous Clinical Trials
1,500 Total Patients Enrolled
6 Trials studying Peripheral Arterial Disease
758 Patients Enrolled for Peripheral Arterial Disease
William Gray, MDPrincipal InvestigatorLankenau Heart Group
8 Previous Clinical Trials
2,644 Total Patients Enrolled
3 Trials studying Peripheral Arterial Disease
467 Patients Enrolled for Peripheral Arterial Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have a sudden loss of blood flow to my limb.My procedure to cross the target lesion with a wire was successful without complications.I had a stroke in the last 3 months.I had a heart attack in the last 30 days.I have had previous treatment on a specific blood vessel with clot-dissolving therapy or surgery.I had a procedure with a drug-coated balloon or stent in my leg in the last 3 months.I have had or will have a blood vessel procedure on the opposite limb around the time of the study.I rely on dialysis for kidney function.I cannot take blood thinners or certain heart medications due to a clotting disorder.My targeted lesion is located in a specific part of my upper leg.My cancer lesion is 180 mm or shorter in total length.My leg pain is moderate to severe, affecting my daily activities.The main artery bringing blood into the area being studied should not have a major blockage, as confirmed by an angiogram.The blood vessel being treated is between 4 and 7 millimeters wide.My blocked artery was opened without complications using a forward approach.My target lesion is near or involves an aneurysm.I currently have or might have an infection.I cannot receive blood transfusions due to my beliefs or other reasons.I am currently on medication to suppress my immune system.Your platelet count is too low (less than 100,000/mm3) or too high (more than 700,000/mm3).My target lesion is severely narrowed, as seen in imaging.You are allergic to any medications that prevent blood from clotting.I had a balloon treatment for a blocked artery within the last 6 months.I needed a blood transfusion due to stomach or intestine bleeding in the last 3 months.I have a blood clot in my target vessel.My condition needs treatment with specific techniques like stenting or laser.My heart blockage is less than 70% after initial treatment and can be treated with available tools.My condition involves new or recurring blockages not treated with a stent, following initial treatments.Your blood vessels have significant twists or other issues that make it difficult to reach the treatment area.I had a procedure to open up blood vessels in my limb using a balloon or stent in the last 3 months.You have had surgery to replace a blood vessel in your abdomen or legs with a man-made tube.I had bypass surgery on the affected area.My kidney function is impaired with a creatinine level of 2.5 mg/dL or higher.My iliac artery disease was treated successfully with less than 30% narrowing remaining.The tumor has a lot of hard calcium deposits.If a blood vessel was previously treated with a stent, the area of concern should be at least 30 mm away from the stent.I have at least one clear artery to my ankle or foot without major narrowing.
Research Study Groups:
This trial has the following groups:- Group 1: Surmodics SurVeil DCB
- Group 2: Medtronic IN.PACT Admiral DCB
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still availability for participants in this clinical trial?
"Clinicaltrials.gov states that this trial, which was initiated on October 23rd 2017 and last edited in June 2022, is not presently recruiting patients. Nonetheless, there are 289 other studies currently admitting participants."
Answered by AI
In which geographical areas is this investigation being conducted?
"This clinical experiment is currently being conducted at 80 distinct venues, including Petoskey, Houston and Camp Hill. To limit travel costs if you choose to participate, it's best to select the site closest to your home."
Answered by AI
Who else is applying?
What site did they apply to?
Cleveland Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
3 vascular surgeons tried to get past my left knee and were unsuccessful.
PatientReceived 2+ prior treatments
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