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RANGER™ Paclitaxel Coated Balloon for Peripheral Arterial Disease (RANGER II SFA Trial)
RANGER II SFA Trial Summary
This trial is testing the safety and effectiveness of the Ranger™ Paclitaxel Coated Balloon for treating lesions in the superficial femoral and proximal popliteal arteries. The long balloon substudy is testing the safety and effectiveness of the Ranger™ Paclitaxel Coated Balloon in the 120, 150 and 200 mm lengths for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions.
- Peripheral Arterial Disease
- Arterial Occlusive Disease
- Atherosclerosis
- Atherosclerotic Plaque
RANGER II SFA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRANGER II SFA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RANGER II SFA Trial Design
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Who is running the clinical trial?
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- The area of interest is the main artery in your thigh (SFA) or pelvis (PPA) down to a specific section (P1 segment).You have ongoing symptoms of poor blood flow in your lower limbs, which are classified based on how severe they are.You have a chronic condition in your legs that causes symptoms like pain or difficulty walking.
- Group 1: Standard Balloon Angioplasty
- Group 2: RANGER™ Paclitaxel Coated Balloon
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Are people with the condition being studied still able to enroll in the research project?
"According to the website, this trial is no longer active. The study was originally posted on March 2nd, 2017 and was most recently edited on October 27th, 2022. There are presently 1253 other trials that are accepting participants."
Does the RANGER™ Paclitaxel Coated Balloon have a good track record?
"The RANGER™ Paclitaxel Coated Balloon was first used in 1997 in a study at City of Hope Comprehensive Cancer Center. So far, 1140 completed studies have used this balloon. 874 clinical trials are currently ongoing, with many of them based in McKinney, Utah."
What objectives does this research hope to accomplish?
"This clinical trial's primary outcome, which will be measured over a 12-month period (6 months for the LB substudy), is the number of major adverse events (MAEs) (primary safety endpoint). Secondary outcomes include the number of participants with clinical success rate assessment (defined as clinical success defined as procedural success without procedural complications including death, major target limb amputation, thrombosis of the target lesion, or clinically-driven TLR prior to discharge), procedural success of angioplasty procedure (defined as procedural success defined as residual stenosis of less than or equal to 50% [non-st"
To what maladies is the RANGER™ Paclitaxel Coated Balloon most often applied?
"The RANGER™ Paclitaxel Coated Balloon is a device that is most frequently used to treat neoplasm metastasis. It has also shown efficacy in the treatment of kaposi sarcoma, advance directives, and fallopian tubes cancer."
Is this clinical trial conducted in many different city locations?
"The study is based out of North Dallas Research Associates, but has 47 other sites in states such as Utah, West virginia, and Ohio."
Does the RANGER™ Paclitaxel Coated Balloon have FDA approval?
"There is already some evidence of efficacy for RANGER™ Paclitaxel Coated Balloon, so it received a score of 3."
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