| NCT ID | NCT07130526 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Essen |
| Condition | PAD - Peripheral Arterial Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-04-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-07-01 with a primary completion date of 2026-04-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. Additionally, the development of chronic, hard-to-heal wounds-especially on the feet and toes-is possible. These wound healing impairments are caused by the insufficient supply of oxygen and nutrients to the affected tissues. The underlying cause of PAD is usually atherosclerosis, a pathological change in the vessel walls due to the accumulation of fats, calcium, and connective tissue. These deposits lead to stiffening and narrowing of the arteries, severely restricting blood flow. Major risk factors for the development of PAD include widespread chronic conditions such as diabetes mellitus, hyperlipidemia (elevated blood lipid levels, e.g., cholesterol), arterial hypertension (high blood pressure), obesity, and tobacco use. Various therapeutic options are available for the treatment of PAD. In addition to conservative therapy (such as supervised exercise training, pharmacological blood thinning, and risk factor management), interventional, minimally invasive treatment using catheter-based techniques is frequently employed. In such procedures, a thin catheter is guided through the vascular system to the affected area of the leg artery. Depending on the type and extent of the arterial narrowing or calcification, one of the following techniques may be applied: Balloon angioplasty: Dilation of the vessel using an inflatable balloon. Lithoplasty: Application of shockwaves to break down calcifications in the arterial wall.
Eligibility Criteria
Inclusion 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07130526 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying PAD - Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07130526 currently recruiting?
Yes, NCT07130526 is actively recruiting participants. Contact the research team at christos.rammos@uk-essen.de for enrollment information.
Where is the NCT07130526 trial being conducted?
This trial is being conducted at Essen, Germany, Essen, Germany.
Who is sponsoring the NCT07130526 clinical trial?
NCT07130526 is sponsored by University Hospital, Essen. The trial plans to enroll 40 participants.