Clinical trial NCT05291247: Shockwave IVL + DES
Official title: Physician-Initiated PMCF Trial Investigating Shockwave Intravascular Lithotripsy and a Drug Eluting Vascular Stent System Deployment for Heavily Calcified Femoropopliteal Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Arterial Disease
Superficial Femoral Artery Stenosis
Calcifications Vascular
Lead sponsor: FCRE (Foundation for Cardiovascular Research and Education)
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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).

Primary outcomes:
measure: Primary Patency
timeFrame: 12 months
measure: Procedural success:
timeFrame: 30 days post procedure
Secondary outcomes:
measure: Primary Patency
timeFrame: 6 months
measure: Target Lesion Revascularization (TLR)
timeFrame: 6- and 12-months
measure: Secondary Patency Rate
timeFrame: 6- and 12-months
measure: Amputation-free Survival rate
timeFrame: 6- and 12-months
measure: Major Amputation Rate
timeFrame: 6- and 12-months
measure: Clinical Success
timeFrame: 6- and 12-months
measure: Absence of Major Adverse Events (MAE)
timeFrame: 6- and 12-months
Other outcomes:
Locations:
city: Arnsberg
country: Germany
facility: Klinikum Hochsauerland
city: Essen
country: Germany
facility: University Hospital Essen
city: Hamburg
country: Germany
facility: University Hospital Eppendorf
city: Karlsbad
country: Germany
facility: SRH Klinikum Karlsbad-Langensteinbach
city: Lünen
country: Germany
facility: St. Marien Hospital
city: Munich
country: Germany
facility: University Hospital LMU Munich
Study officials:
affiliation: Vascular Department, LMU Munich
name: Konstantinos Stavroulakis, MD
role: PRINCIPAL_INVESTIGATOR
References: