Shockwave IVL + DES

Peripheral Arterial Disease Clinical Trial

— Shockwave DES  

Official title:

Physician-Initiated PMCF Trial Investigating Shockwave Intravascular Lithotripsy and a Drug Eluting Vascular Stent System Deployment for Heavily Calcified Femoropopliteal Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05291247
• Other study ID #: FCRE-210505
• Status: Recruiting
• Start date: July 22, 2022
• Est. completion date: October 2024

Study information

• Verified date: July 2023
• Source: FCRE (Foundation for Cardiovascular Research and Education)
• Contact: Annelena Held-Wehmöller, PhD
• Phone: +4915785128140
• Email: shockwave_des[@]fcre.eu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this clinical investigation is to evaluate, in a controlled setting, the 12 months safety and efficacy of the combination of Shockwave Intravascular Lithotripsy and a polymer coated Drug Eluting Stent device, for PACSS 3 and PACSS 4 calcified femoropopliteal disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

Inclusion Criteria:

• Subject must be between 21 and 85 years old
• Clinical diagnosis of symptomatic peripheral artery disease, defined by Rutherford Becker Classification score 3-5
• Willing to comply with the specified follow-up evaluation
• Written informed consent prior to any study procedures
• Stenotic, restenotic after PTA or occlusive lesion(s) located in the native

Superficial Femoral Artery (SFA) and/or proximal Popliteal Artery (PPA):

1. Degree of stenosis = 70% by visual agiographic assessment

2. Vessel diameter = 4 and = 6 mm

3. Total lesion length (or series of lesions) = 30 mm and 210 mm (Note: Lesion segment(s) must be filly covered with one or two overlapping DES stent (s) be fully covered with one or two overlapping DES stent(s)

4. Target lesion located at least three centimeters above the inferior edge of the femur

• Severity of calcification PACSS 3-4
• Patent infrapopliteal and popliteal artery; i.e. single vessel runoff or better with at least one of three vessels patent (>50% stenosis) to the ankle or foot with no planned intervention.
• Study entry after successful target lesion crossing of the guidewire (guidewire located intraluminally or subintimally); Both crossing devices as well as retrograde recanalization can be used.
• Non-target lesion interventions to restore adequate blood flow, in the same index procedure are allowed. This intervention must be prior to the treatment of the study lesion and should be completed successfully.

Exclusion Criteria:

• Not treated ipsilateral significant (>50%) stenosis of the iliac arteries
• Non severely calcified disease (absence of calcification, PACSS 1, PACSS 2)
• Significant (>50%) stenosis of all infrapopliteal arteries, no patent artery to the foot
• Angiographic evidence of thrombus within the target vessel
• Thrombolysis within 72 hours prior to the index procedure
• Previously stented target lesion / vessel
• Subjects who have undergone prior surgery of the target lesion SFA/PPA to treat atherosclerotic disease
• Bypass Anastomosis stenosis
• Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy
• Recent MI or stroke <30 days prior to the index procedure
• Life expectancy less than 24 months
• Known or suspected active infection at the time of the index procedure
• Known or suspected major allergies or contraindications to aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, or contrast agent
• Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimalparticipation in the study
• The subject is currently participating in another drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
• Female subjects pregnant, breastfeeding, of childbearing potential who are planning to become pregnant in the next 5 years.
• End-stage-renal disease
• Presence of Severe Ischemic Ulcers or frank gangrene (Rutherford class 6).

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Superficial Femoral Artery Stenosis
• Vascular Calcification

Intervention

Device:
• Peripheral lithotripsy system (Shockwave Medical)
The combination of Shockwave Intravascular Lithotripsy and a polymer coated Drug Eluting Stent device for calcified femoropopliteal disease.

Locations

Country	Name	City	State
Germany	Klinikum Hochsauerland	Arnsberg
Germany	University Hospital Essen	Essen
Germany	University Hospital Eppendorf	Hamburg
Germany	SRH Klinikum Karlsbad-Langensteinbach	Karlsbad
Germany	St. Marien Hospital	Lünen
Germany	University Hospital LMU Munich	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Sabrina Overhagen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Patency	Defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without Target Lesion Revascularization (TLR)	12 months
Primary	Procedural success:	Defined as technical success and completion of the procedure without complications , meaning successful treatment of the vessels (technical success) in the absence of: vessel rupture or perforation that require an intervention; need for emergency surgical revascularization of target limb; symptomatic thrombus or distal emboli that require surgical, mechanical, or pharmacologic means to improve flow and extend hospitalization; unplanned above the ankle amputation; major adverse cardiovascular events (defined as composite of total death, myocardial infarction, coronary revascularization and stroke).	30 days post procedure
Secondary	Primary Patency	Defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50 systolic velocity ratio no greater than 2,4) and without Target Lesion Revascularization (TLR)	6 months
Secondary	Target Lesion Revascularization (TLR)	Defined as the need for target lesion revascularization after index procedure.	6- and 12-months
Secondary	Secondary Patency Rate	Defined as restored flow in the treated segment after occlusion or restenosis.	6- and 12-months
Secondary	Amputation-free Survival rate	Defined as the time until a major amputation of the index limb and/or death of any cause, whichever occurred first.	6- and 12-months
Secondary	Major Amputation Rate	Defined as any aboveankle amputation.	6- and 12-months
Secondary	Clinical Success	Defined as an improvement of the Rutherford Becker Classification of one class or more, as compared to the preprocedure Rutherford Becker Classification.	6- and 12-months
Secondary	Absence of Major Adverse Events (MAE)	Acute Coronary Syndrome, Stroke, Death, Major Amputation or TLR.	6- and 12-months