Distrupt Stiffness Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity Hospital, Essen

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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,

  • POBA plus DCB

    Device

    Standard of Care

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: POBA plus DCBActive comparator 1 intervention
Group B: Intravascular Lithotripsy (IVL) plus DCBActive comparator 1 intervention

Trial outcomes

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).

Time frame
1 day and 30 days follow-up

Secondary outcomes

1

FMD/NMD analysis of the target lesion

• Endothelial function and endothelial independent function as determined by FMD/NMD analysis of the target lesion. FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery. NMD represents the diameter change of the femoral artery after nitroglycerine-mediated vasodilation.

Time frame
1 day and 30 days follow-up
2

PWV

Aortic stiffness determined by pulse wave velocity (PWV)

Time frame
1 day and 30 days follow-up
3

ABI

Peripheral perfusion determined by ABI (ankle brachial index)

Time frame
1 day and 30 days follow-up
4

Primary patency (PP)

Primary patency (PP) evaluated by clinical assessment by ultrasound

Time frame
1 day and 30 days follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Essen

Lead sponsor

Shockwave Medical, Inc.

Collaborator