Stenotic or occlusive disease in the infrainguinal arteries, with moderate to severe calcified lesions by visual angiography. Circulatory System Stenotic or occlusive disease in the infrainguinal arteries, with moderate to severe calcified lesions by visual angiography.
Conditions
Interventions
Patients will be prepped as standard of care at the facility and undergo angiography and potentially intravascular ultrasound (IVUS) scans so that the lesion can be visualised. A semi-compliant balloo
Sponsors
The Spectranetics Corporation (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient aged between 18 and 80 years 2. Patient agrees to participate and comply with the protocol by signing a Medical Ethics Committee approved consent form 3. Subject meets the criteria for treatment according to Instructions for Use (IFU) 4. Peripheral arterial disease with a documented Rutherford Class 2-5 5. Moderate or severe calcium to include fluoroscopic evidence of calcification: 5.1.On parallel sides of the vessel 5.2. Extending =50% the length of the balloon 6. Balloon resistant calcific lesion apparent on angiogram by inability to dilatate lesion to less than 50% DS 7. De novo or restenotic lesion of the SFA, popliteal or tibial artery 8. Reference vessel diameter 3.0-6.5mm 9. At least one patent runoff vessel to the foot
Exclusion criteria
Exclusion criteria: 1. Patient is pregnant or breast feeding (Female subjects of childbearing potential must have negative serum pregnancy test 7 days prior to treatment) 2. Life expectancy < 12 months 3. Evidence of Acute Limb Ischemia within 7 days prior to procedure 4. CVA < 60 days prior to procedure. 5. Myocardial infarction < 60 days prior to procedure. 6. Known contraindication to aspirin, antiplatelet/anti-coagulant therapies required for procedure/follow up. 7. Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure. 8. Uncontrolled hypercoagulability or history of HIT or HITTS syndrome 9. Serum creatinine = 2.5 mg/dL tested within a week prior to procedure 10. Patient is simultaneously participating in another investigational drug or device study that will interfere with the 30 day Safety Endpoint 11. Patient is not eligible for bypass surgery or endovascular intervention 12. Planned major amputation 13. Lesion located within a stent or endograft 14. Planned or predicted cardiovascular surgical or interventional procedures prior to completion of the 30–day follow–up (including, but not limited to aortic, renal, cardiac, carotid, contralateral femoropopliteal, and contralateral below the knee 15. Ipsilateral and/or contralateral iliac (or common femoral) artery stenosis =50% DS that is not successfully treated prior to index procedure 16. Target lesion could not be crossed with the guidewire or support catheter 17. Target lesion length(s) exceed 200mm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Minimum arterial lumen diameter is measured using angiographic at baseline and post-Thor treatment 2. The ability to dilate a previously balloon-resistant lesion after Thor treatment with low pressure balloon inflation is recorded during procedure 3. Any MAE, defined as death from any cause, repeat target vessel revascularization with endovascular intervention or bypass surgery, or amputation of target limb through 30-day follow-up (total of 37 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Calcification score is a visual assessment by using angiographic at baseline and post-Thor treatment 2. Angiographic success (defined as <30% residual stenosis) is a visual assessment by angiography at baseline and post-Thor treatment 3. Rate of procedural adverse events are measured by visual inspection of angiograms during procedure | — |
Countries
Switzerland
Contacts
Public ContactHailey Austin
Outcome results
None listed