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New treatment option for PAD - Peripheral Arterial Disease
Official title Distrupt Stiffness Trial
ClinicalTrials.gov ID: NCT07130526
What this study is testing
- What it's testing
- Typical symptoms of PAD include exercise-induced pain in the legs (known as intermittent claudication), which can significantly limit pain-free walking. In more advanced stages, pain may also occur at rest.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Peripheral artery disease
- Severe Calcification PACCS 2,3 and 4
- Target lesions in distal EIA, CFA, prox. SFA or PA
- Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, 4 and 5
- Planed peripheral intervention TASC A-D
You likely can't join if
- Target lesions with no optimal visualization in ultrasound
- Instent-Restenosis
- Thrombolysis within 72 hours prior to the index procedure
- Aneurysm formations in the femoral artery or popliteal artery
- Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy
- Unstable angina pectoris at the time of the enrolment
See the full eligibility criteria
- Peripheral artery disease
- Severe Calcification PACCS 2,3 and 4
- Target lesions in distal EIA, CFA, prox. SFA or PA
- Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, 4 and 5
- Planed peripheral intervention TASC A-D
- Subject must be between 18 and 85 years old
- Willing to comply with the specified follow-up evaluation
- Written informed consent prior to any study procedures
- Target lesions with no optimal visualization in ultrasound
- Instent-Restenosis
- Thrombolysis within 72 hours prior to the index procedure
- Aneurysm formations in the femoral artery or popliteal artery
- Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy
- Unstable angina pectoris at the time of the enrolment
- Recent myocardial infarction or stroke \< 30 days prior to the index procedure
- Life expectancy less than 12 months
- Septicemia at the time of enrolment
- Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb
- Known or suspected allergies or contraindications to aspirin, clopidogrel or heparin
The study team makes the final eligibility decision.
Where it's taking place
- Essen, North Rhine-Westphalia, Germany
- Essen, Germany
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, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Essen, North Rhine-Westphalia, Germany; Essen, Germany. 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.