Peripheral Arterial Disease Clinical Trial
— Shockwave DESOfficial title:
Physician-Initiated PMCF Trial Investigating Shockwave Intravascular Lithotripsy and a Drug Eluting Vascular Stent System Deployment for Heavily Calcified Femoropopliteal Disease
NCT number | NCT05291247 |
Other study ID # | FCRE-210505 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 22, 2022 |
Est. completion date | October 2024 |
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.
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). |
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 |
Lead Sponsor | Collaborator |
---|---|
Dr. Sabrina Overhagen |
Germany,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06032065 -
Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)
|
Phase 3 | |
Active, not recruiting |
NCT03987061 -
MOTIV Bioresorbable Scaffold in BTK Artery Disease
|
N/A | |
Recruiting |
NCT03506633 -
Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients
|
N/A | |
Active, not recruiting |
NCT03506646 -
Dietary Nitrate Supplementation and Thermoregulation
|
N/A | |
Active, not recruiting |
NCT04677725 -
NEtwork to Control ATherothrombosis (NEAT Registry)
|
||
Recruiting |
NCT05961943 -
RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients
|
N/A | |
Recruiting |
NCT06047002 -
Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
|
||
Completed |
NCT03185052 -
Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach
|
N/A | |
Recruiting |
NCT05992896 -
A Study of Loco-Regional Liposomal Bupivacaine Injection
|
Phase 4 | |
Completed |
NCT04635501 -
AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial
|
N/A | |
Recruiting |
NCT04584632 -
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
|
N/A | |
Withdrawn |
NCT03994185 -
The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease
|
N/A | |
Withdrawn |
NCT03538392 -
Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
|
||
Recruiting |
NCT02915796 -
Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty
|
Phase 1 | |
Active, not recruiting |
NCT02900924 -
Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
|
||
Completed |
NCT02901847 -
To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.
|
N/A | |
Not yet recruiting |
NCT02455726 -
Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease
|
N/A | |
Withdrawn |
NCT02126540 -
Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries
|
N/A | |
Not yet recruiting |
NCT02387450 -
Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication
|
Phase 2/Phase 3 | |
Completed |
NCT02022423 -
Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease
|
N/A |