Distrupt Stiffness Trial

NCT07130526 | Recruiting

• 1 other identifier: FRM-68717
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

PAD - Peripheral Arterial Disease; PAD

Keywords

pad; peripheral artery disease; intravascular lithotripsy

Outcome Measures

Primary Outcomes (1)

• FDC

  To determine changes in vessel compliance before and after IVL treatment and after 1 month compared to POBA in symptomatic PAD as determined by fractional diameter change (FDC).

  1 day and 30 days follow-up

Secondary Outcomes (8)

• FMD/NMD analysis of the target lesion

  1 day and 30 days follow-up

• PWV

  1 day and 30 days follow-up

• ABI

  1 day and 30 days follow-up

• Primary patency (PP)

  1 day and 30 days follow-up

• AIX

  1 day and 30 days follow-up

Study Arms (2)

POBA plus DCB

ACTIVE COMPARATOR

Device: POBA plus DCB

Intravascular Lithotripsy (IVL) plus DCB

ACTIVE COMPARATOR

Device: Intravascular Lithotripsy (IVL) plus DCB

Interventions

Intravascular Lithotripsy (IVL) plus DCB DEVICE

The device under investigation is the Peripheral Lithotripsy System (Shockwave Medical, Fremont, California). Miniaturized and arrayed lithotripsy emitters create a localized field effect at the site of the calcium. The Peripheral Lithotripsy System is CE-marked for peripheral arterial disease and for this study, will be used within its indication for use. This included the following: intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral and popliteal arteries. The IVL catheter is delivered across a calcified lesion over an 0.014'' wire and the integrated balloon is expanded to 4atm to facilitate efficient energy transfer. An electrical discharge from the emitters vaporizes the fluid within the balloon, creating a rapidly expanding and collapsing bubble that generates sonic pressure waves. The waves create a localized field effect that travels through soft vascular tissue,

Intravascular Lithotripsy (IVL) plus DCB

POBA plus DCB DEVICE

Standard of Care

POBA plus DCB

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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

You may not qualify 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
• 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

Sponsors & Collaborators

• University Hospital, Essen: lead
• Shockwave Medical, Inc.: collaborator

Study Sites (2)

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

Essen, North Rhine-Westphalia, 45147, Germany

NOT YET RECRUITING

University of Duisburg-Essen

Essen, 45147, Germany

RECRUITING

MeSH Terms

Conditions

Peripheral Vascular Diseases; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Central Study Contacts

Christos Rammos, Prof. Dr. med.

CONTACT

0201-723-4801; christos.rammos@uk-essen.de

Daniel Messiha, Dr. med.

CONTACT

0201-723-4801; daniel.messiha@uk-essen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: August 19, 2025
• Study Start: July 1, 2025
• Primary Completion: April 20, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)