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Compares treatment options for Arterial Disease of Legs
Official title Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease
ClinicalTrials.gov ID: NCT06182397
What this study is testing
- What it's testing
- This is a Pivotal, Prospective, randomized, two arm, placebo controlled, single-blind, multicenter trial that will be conducted at approximately 80 sites; approx. 50 sites with at least 50% of subjects will be recruited from USA and approx.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- Age ≥ 21 years or minimum age (is allowed the inclusion of people \> 21 years OR adulthood minimum age (depending on the US state regulations)
- Rutherford class 4 with documented WIFI score, not exceeding more than 30% of target patient population.
- Rutherford class 5 to 6 in the target limb with documented WIFI score. Intraoperative
- Single or sequential de novo or re-stenotic lesions (stenosis of \> 50% or occlusions) from 2 to 20cm in the proximal 200mm of below the knee...
- Target vessel has angiographically documented unimpaired (\<50% stenosis) run off into a named Tibio-pedal artery (Peroneal, Anterior Tibial/...
You likely can't join if
- Comorbid conditions limiting life expectancy ≤ 1 year
- Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet
- Subject is lactating, pregnant or planning to become pregnant during the course of the study
- Subject with extensive tissue loss salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputation. This includes...
- Osteomyelitis including and/or proximal to the metatarsal head
- Gangrene involving the plantar skin of the forefoot, midfoot,or heel
See the full eligibility criteria
- Age ≥ 21 years or minimum age (is allowed the inclusion of people \> 21 years OR adulthood minimum age (depending on the US state regulations)
- Rutherford class 4 with documented WIFI score, not exceeding more than 30% of target patient population.
- Rutherford class 5 to 6 in the target limb with documented WIFI score. Intraoperative
- Single or sequential de novo or re-stenotic lesions (stenosis of \> 50% or occlusions) from 2 to 20cm in the proximal 200mm of below the knee arteries. Lesion is considered as one lesion if there is maximum of 30 mm gap...
- Target vessel has angiographically documented unimpaired (\<50% stenosis) run off into a named Tibio-pedal artery (Peroneal, Anterior Tibial/ Dorsalis Pedis/ Posterior Tibial Artery)
- Comorbid conditions limiting life expectancy ≤ 1 year
- Subject is currently participating in another investigational drug or device study that has not reached first primary endpoint yet
- Subject is lactating, pregnant or planning to become pregnant during the course of the study
- Subject with extensive tissue loss salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputation. This includes people with:
- Osteomyelitis including and/or proximal to the metatarsal head
- Gangrene involving the plantar skin of the forefoot, midfoot,or heel
- Deep ulcer or large shallow ulcer (\> 3 cm) involving the plantar skin of the forefoot, midfoot, or heel
- Full thickness heel ulcer with/without calcaneal involvement
- Any wound with calcaneal bone involvement
- Wounds that are deemed to be neuropathic or non-ischemic in nature
- Wounds that would require flap coverage or complex wound management for large soft tissue defect
- Full thickness wounds on the dorsum of the foot with exposed tendon or bone
- Prior bypass surgery of target vessel
- Planned amputation of the target limb (major)
- Previously implanted stent in the target lesion
- Vulnerable or protected adults
- Bleeding diathesis or another disorder (i.e. gastrointestinal ulceration,etc) which would prevent the use of mandated antiplatelet agents
- Known allergy to sirolimus
- people with severe (Stage 4) renal disease, defined eGFR \< 30. Intraoperative exclusion criteria:
- Failure to successfully cross the target lesion with a guide wire
- Target vessel has lesions extending beyond the ankle joint
- Failure to obtain \<30% residual stenosis prior to randomization
- Lesions requiring treatment through retrograde access . Retrograde wire crossing is allowed but treatment must be performed from the antegrade approach.
- Use of commercially available DCBs, bare metal stents, drug eluting stents, specialty balloons or atherectomy devices at the target lesions. (Non-compliant balloons are not considered specialty balloons). For Inflow and...
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- Clearwater, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Davenport, Iowa, United States
- Des Moines, Iowa, United States
- Farmington Hills, Michigan, United States
- Browns Mills, New Jersey, United States
- Marlton, New Jersey, United States
- Lake Success, New York, United States
- New York, New York, United States
- Roslyn, New York, United States
- Valhalla, New York, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Bryn Mawr, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Charleston, South Carolina, United States
- Austin, Texas, United States
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Los Angeles, California, United States; Clearwater, Florida, United States; Miami, Florida, United States; Tampa, Florida, United States; Davenport, Iowa, United States and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.