- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05291247
Shockwave IVL + DES (Shockwave DES)
July 4, 2023 updated by: Dr. Sabrina Overhagen
Physician-Initiated PMCF Trial Investigating Shockwave Intravascular Lithotripsy and a Drug Eluting Vascular Stent System Deployment for Heavily Calcified Femoropopliteal Disease
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Annelena Held-Wehmöller, PhD
- Phone Number: +4915785128140
- Email: shockwave_des@fcre.eu
Study Locations
-
-
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Arnsberg, Germany
- Recruiting
- Klinikum Hochsauerland
-
Contact:
- Michael Lichtenberg, MD
-
Essen, Germany
- Recruiting
- University Hospital Essen
-
Contact:
- Christos Rammos, MD
-
Hamburg, Germany
- Recruiting
- University Hospital Eppendorf
-
Contact:
- Erwin Blessing, MD
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Karlsbad, Germany
- Recruiting
- SRH Klinikum Karlsbad-Langensteinbach
-
Contact:
- Ralph Oberacker, MD
-
Lünen, Germany
- Not yet recruiting
- St. Marien Hospital
-
Contact:
- Martin Schröder, MD
-
Munich, Germany
- Recruiting
- University Hospital LMU Munich
-
Contact:
- Konstantinos Stavroulakis, MD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
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.
Description
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):
- 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.
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Heavily calcified femoropopliteal disease
|
The combination of Shockwave Intravascular Lithotripsy and a polymer coated Drug Eluting Stent device for calcified femoropopliteal disease.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Patency
Time Frame: 12 months
|
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:
Time Frame: 30 days post procedure
|
Defined as technical success and completion of the procedure without complications , meaning successful treatment of the vessels (technical success) in the absence of:
|
30 days post procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Patency
Time Frame: 6 months
|
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
|
Target Lesion Revascularization (TLR)
Time Frame: 6- and 12-months
|
Defined as the need for target lesion revascularization after index procedure.
|
6- and 12-months
|
Secondary Patency Rate
Time Frame: 6- and 12-months
|
Defined as restored flow in the treated segment after occlusion or restenosis.
|
6- and 12-months
|
Amputation-free Survival rate
Time Frame: 6- and 12-months
|
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
|
Major Amputation Rate
Time Frame: 6- and 12-months
|
Defined as any aboveankle amputation.
|
6- and 12-months
|
Clinical Success
Time Frame: 6- and 12-months
|
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
|
Absence of Major Adverse Events (MAE)
Time Frame: 6- and 12-months
|
Acute Coronary Syndrome, Stroke, Death, Major Amputation or TLR.
|
6- and 12-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Konstantinos Stavroulakis, MD, Vascular Department, LMU Munich
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 22, 2022
Primary Completion (Estimated)
July 1, 2024
Study Completion (Estimated)
October 1, 2024
Study Registration Dates
First Submitted
November 21, 2021
First Submitted That Met QC Criteria
March 21, 2022
First Posted (Actual)
March 22, 2022
Study Record Updates
Last Update Posted (Actual)
July 6, 2023
Last Update Submitted That Met QC Criteria
July 4, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FCRE-210505
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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