Peripheral Arterial Disease
Conditions
Keywords
Calcification, Lithotripsy
Brief summary
This study is an investigator-initiated, prospective, single-center, 1:1 randomized pilot study. The trial evaluates the safety and efficacy of intravascular lithotripsy in comparison to standard lesion preparation using standard and/or high-pressure balloon angioplasty in patients with femoropopliteal artery disease. All patients will receive subsequent Supera stent implantation at the operator's discretion. Additional standard nitinol bare metal stent (BMS), drug-eluting stent or covered stent implantation is at the operator's discretion. Patients will be stratified for total occlusions.
Detailed description
All enrolled subjects will be followed up through 60 months. At 6, 12, 24, 36 MFU after index procedure the incidence of restenosis will be assessed by DUS.
Interventions
PROCEDUREStandard lesion preparation
Lesion preparation with Standard and/or High-Pressure Balloon Angioplasty
PROCEDUREIntravascular lithotripsy
Lesion preparation with Shockwave Medical Peripheral Lithotripsy System
Sponsors
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject age ≥ 18 * Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved inform consent form * Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing * Rutherford Classification 2-5 * Subject has a de novo or restenotic lesion in SFA and/or PPA not exceeding the medial femoral epicondyle with ≥ 70% stenosis documented angiographically * No previous stent in the target lesion, if target vessel was previously stented the stent should be at least 3cm apart * Target lesion length is ≥ 10cm, no maximum lesion length limit * Severe calcification on fluoroscopy defined by PACSS Grade 4: 1) bilateral calcification and 2) extending ≥50mm in length * Multiple lesions with max. 3cm healthy vessel segment in between lesions can be considered at the discretion of the operator as one lesion * Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation * Patency of at least one infrapopliteal artery to the ankle (\< 50% diameter stenosis) in continuity with the native femoropopliteal artery * A guidewire has successfully traversed the target treatment segment (both intraluminal and subintimal crossing allowed)
Exclusion criteria
* Failure to successfully cross the target lesion * Presence of fresh thrombus in the lesion * Presence of aneurysm in the target vessel/s * Presence of a stent in the target lesion, at least 3cm from any previously stent in target vessel * Prior vascular surgery of the target lesion * Stroke or heart attack within 3 months prior to enrollment * Enrolled in another investigational drug, device or biologic study that has not reached the primary endpoint * Life expectancy of less than one year * Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies or contrast media that cannot be adequately pre-treated prior to index procedure * Rutherford Classification of 0, 1, or 6 * Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy * Receiving immunosuppressant therapy * Pregnant or breast-feeding females * History of major amputation (defined as amputation above ankle joint) in the same limb as the target lesion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary efficacy | During the Procedure | Procedural success defined as residual stenosis ≤ 30% without flow-limiting dissection (≥Grade D) in the final angiogram and without the need of additional stent implantation. |
| Rate of primary outcome events | 12 month | Composite endpoint defined as freedom from device and procedure-related death, freedom from both target limb major amputation and clinically-driven target lesion revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of vessel rupture | During the Procedure | Rate of vessel rupture |
| Need of additional stent implantation | During the Procedure | Need of additional stent implantation |
| Procedure Time (min) | During the Procedure | Procedure Time (min) |
| Fluoroscopy Duration (min) | During the Procedure | Fluoroscopy Duration (min) |
| Radiation dose area product | During the Procedure | Radiation dose area product |
| Additional need of intra-procedural pain medication | During the Procedure | Additional need of intra-procedural pain medication |
| Perception of procedural pain evaluated using a numerical rating scale from 0 (no pain) to 10 (severest pain) | During the Procedure | Perception of procedural pain evaluated using a numerical rating scale from 0 (no pain) to 10 (severest pain) |
| Rate of any dissections after lesion preparation and in the final angiogram | During the Procedure | Rate of any dissections after lesion preparation and in the final angiogram |
| Rate of primary patency | 6, 12, 24 and 36 months | Rate of primary patency |
| Rate of Duplex-defined binary restenosis (PVR >2.4) of the target lesion | post-procedure until discharge from hospital (up to 48 hours) and at 6, 12, 24 and 36 months or at any time of re-intervention | Rate of Duplex-defined binary restenosis (PVR \>2.4) of the target lesion |
| Rate of Clinically-driven Target lesion revascularization | 30 days, 6, 12, 24, 36, 48 and 60 months | Rate of Clinically-driven Target lesion revascularization |
| Rate of Freedom from Major Adverse Event (defined as death, Target lesion revascularization, Target vessel revascularization and target limb major amputation) | 30 days, 6, 12, 24, 36, 48 and 60 months | Rate of Freedom from Major Adverse Event (defined as death, Target lesion revascularization, Target vessel revascularization and target limb major amputation) |
| Rate of All-cause mortality | 30 days, 6, 12, 24, 36, 48 and 60 months | Rate of All-cause mortality |
| Ankle-brachial index (ABI) | 6, 12, 24 and 36 months | The ABI is calculated by dividing the highest of the dorsalis pedis and posterior tibial pressures in each leg by the highest of the brachial pressures. Value less than 0.90 indicates a diagnosis of PAD. |
| Rutherford Classification | 6, 12, 24 and 36 months | Rutherford Classification Scale from 0=Asymptomatic, 1=Mild claudication, 2=Moderate claudication, 3=Severe claudication, 4=Ischemic rest pain, 5=Minor tissue loss up to worst classification 6=Major tissue loss |
| Walking Impairment Questionnaire (WIQ) | 6, 12, 24 and 36 months | The products are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (representing the inability to perform any of the tasks) to 100 (representing no difficult with any of the tasks). |
| EQ-5D-5L questionnaire | 6, 12, 24 and 36 months | The EQ-5D-5L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: o problems, slight problems, moderate problems, severe problems and extreme problems. |
| EQ VAS | 6, 12, 24 and 36 months | The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 100% 'Best imaginable health state' and 0% 'Worst imaginable health state'. |
Countries
Germany
Contacts
Primary ContactSabine Steiner, Prof. Dr.
Backup ContactJanine Brunotte
Outcome results
None listed