Shockwave IVL + DES

NCT05291247 | Completed

• 1 other identifier: FCRE-210505
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Peripheral Arterial Disease; Superficial Femoral Artery Stenosis; Calcifications Vascular

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Primary Patency

  6 months

• Target Lesion Revascularization (TLR)

  6- and 12-months

• Secondary Patency Rate

  6- and 12-months

• Amputation-free Survival rate

  6- and 12-months

• Major Amputation Rate

  6- and 12-months

Study Arms (1)

Heavily calcified femoropopliteal disease

* 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

Device: Peripheral lithotripsy system (Shockwave Medical)

Interventions

Peripheral lithotripsy system (Shockwave Medical) DEVICE

The combination of Shockwave Intravascular Lithotripsy and a polymer coated Drug Eluting Stent device for calcified femoropopliteal disease.

Heavily calcified femoropopliteal disease

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient population for this study are patients with a diminished blood flow in their heavily calcified femoropopliteal lesions, who need a reintervention.

You may qualify if:

• 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):
• Degree of stenosis ≥ 70% by visual agiographic assessment
• Vessel diameter ≥ 4 and ≥ 6 mm
• 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)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Marc Bosiers, MD: lead

Study Sites (6)

SRH Klinikum Karlsbad-Langensteinbach

Baden-Baden, Baden-Wurttemberg, 76307, Germany

Location

University Hospital LMU Munich

Munich, Bavaria, 80337, Germany

Location

University Hospital Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

Location

Klinikum Hochsauerland

Arnsberg, North Rhine-Westphalia, 59759, Germany

Location

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

St. Marien Hospital Lünen

Lünen, North Rhine-Westphalia, 44534, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Vascular Calcification

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Konstantinos Stavroulakis, MD

  Vascular Department, LMU Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 21, 2021
• First Posted: March 22, 2022
• Study Start: July 22, 2022
• Primary Completion: September 23, 2025
• Study Completion: February 10, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6)