Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT07130526

Distrupt Stiffness Trial

Led by University Hospital, Essen · Updated on 2025-08-19

40

Participants Needed

2

Research Sites

50 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Essen

Lead Sponsor

S

Shockwave Medical, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Distrupt Stiffness Trial

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Peripheral artery disease
  • Severe calcification classified as PACCS 2, 3, or 4
  • Target lesions located in distal external iliac artery, common femoral artery, proximal superficial femoral artery, or popliteal artery
  • Clinical diagnosis of chronic, symptomatic lower limb ischemia with Rutherford stages 2, 3, 4, or 5
  • Planned peripheral intervention classified as TASC A to D
  • Age between 18 and 85 years old
  • Willingness to comply with all specified follow-up evaluations
  • Signed written informed consent before any study procedures
Not Eligible

You will not qualify if you...

  • Target lesions that cannot be optimally visualized by ultrasound
  • Instent restenosis at the lesion site
  • Thrombolysis treatment within 72 hours before the procedure
  • Aneurysm in the femoral or popliteal artery
  • Presence of hepatic insufficiency, deep vein thrombosis, coagulation disorders, or current immunosuppressant therapy
  • Unstable angina pectoris at enrollment
  • Myocardial infarction or stroke within 30 days before the procedure
  • Life expectancy less than 12 months
  • Septicemia at enrollment
  • Active infection at the procedure time except for infections of a lower extremity wound on the target limb
  • Known or suspected allergies or contraindications to aspirin, clopidogrel, or heparin

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

West German Heart and Vascular Center, Clinic for Cardiology and Vascular Medicine, Universtiy Hospital Essen

Essen, North Rhine-Westphalia, Germany, 45147

Not Yet Recruiting

2

University of Duisburg-Essen

Essen, Germany, 45147

Actively Recruiting

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Research Team

C

Christos Rammos, Prof. Dr. med.

CONTACT

D

Daniel Messiha, Dr. med.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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