Shockwave IVL + DES

NCT ID: NCT05291247

Last Updated: 2023-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-22
• Study Completion Date: 2024-10-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Peripheral lithotripsy system (Shockwave Medical)

Intervention Type: DEVICE

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

Interventions

Peripheral lithotripsy system (Shockwave Medical)

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

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Sabrina Overhagen

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sabrina Overhagen

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Konstantinos Stavroulakis, MD

Role: PRINCIPAL_INVESTIGATOR

Vascular Department, LMU Munich

Locations

Klinikum Hochsauerland

Arnsberg, , Germany

Site Status: RECRUITING

University Hospital Essen

Essen, , Germany

Site Status: RECRUITING

University Hospital Eppendorf

Hamburg, , Germany

Site Status: RECRUITING

SRH Klinikum Karlsbad-Langensteinbach

Karlsbad, , Germany

Site Status: RECRUITING

St. Marien Hospital

Lünen, , Germany

Site Status: NOT_YET_RECRUITING

University Hospital LMU Munich

Munich, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Annelena Held-Wehmöller, PhD

Role: CONTACT

shockwave_des@fcre.eu

+4915785128140

Facility Contacts

Michael Lichtenberg, MD

Role: primary

Christos Rammos, MD

Role: primary

Erwin Blessing, MD

Role: primary

Ralph Oberacker, MD

Role: primary

Martin Schröder, MD

Role: primary

Konstantinos Stavroulakis, MD

Role: primary

Other Identifiers

FCRE-210505

Identifier Type: -

Identifier Source: org_study_id