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Compares treatment options for Peripheral Arterial Disease
Official title Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions
ClinicalTrials.gov ID: NCT06112171
What this study is testing
- What it's testing
- This study is an investigator-initiated, prospective, single-center, 1:1 randomized pilot study. The trial evaluates the safety and efficacy of intravascular lithotripsy in comparison to standard lesion preparation using standard and/or high-pressure balloon angioplasty in patients with femoropopliteal artery disease.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject age ≥ 18
- Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved inform consent form
- Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing
- Rutherford Classification 2-5
- Subject has a de novo or restenotic lesion in SFA and/or PPA not exceeding the medial femoral epicondyle with ≥ 70% stenosis documented...
You likely can't join if
- Failure to successfully cross the target lesion
- Presence of fresh thrombus in the lesion
- Presence of aneurysm in the target vessel/s
- Presence of a stent in the target lesion, at least 3cm from any previously stent in target vessel
- Prior vascular surgery of the target lesion
- Stroke or heart attack within 3 months prior to enrollment
See the full eligibility criteria
- Subject age ≥ 18
- Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved inform consent form
- Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing
- Rutherford Classification 2-5
- Subject has a de novo or restenotic lesion in SFA and/or PPA not exceeding the medial femoral epicondyle with ≥ 70% stenosis documented angiographically
- No previous stent in the target lesion, if target vessel was previously stented the stent should be at least 3cm apart
- Target lesion length is ≥ 10cm, no maximum lesion length limit
- Severe calcification on fluoroscopy defined by PACSS Grade 4: 1) bilateral calcification and 2) extending ≥50mm in length
- Multiple lesions with max. 3cm healthy vessel segment in between lesions can be considered at the discretion of the operator as one lesion
- Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation
- Patency of at least one infrapopliteal artery to the ankle (\< 50% diameter stenosis) in continuity with the native femoropopliteal artery
- A guidewire has successfully traversed the target treatment segment (both intraluminal and subintimal crossing allowed)
- Failure to successfully cross the target lesion
- Presence of fresh thrombus in the lesion
- Presence of aneurysm in the target vessel/s
- Presence of a stent in the target lesion, at least 3cm from any previously stent in target vessel
- Prior vascular surgery of the target lesion
- Stroke or heart attack within 3 months prior to enrollment
- Enrolled in another investigational drug, device or biologic study that has not reached the primary endpoint
- Life expectancy of less than one year
- Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies or contrast media that cannot be adequately pre-treated prior to index procedure
- Rutherford Classification of 0, 1, or 6
- Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
- Receiving immunosuppressant therapy
- Pregnant or breast-feeding females
- History of major amputation (defined as amputation above ankle joint) in the same limb as the target lesion
The study team makes the final eligibility decision.
Where it's taking place
- Leipzig, Saxony, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leipzig, Saxony, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.