Health Condition 1: I739- Peripheral vascular disease, unspecified
Conditions
Interventions
Intervention1: Peripherics paclitaxel-coated
PTA balloon catheter: Peripherics Paclitaxel-coated PTA Balloon Catheter are over-the-wire (OTW) percutaneous transluminal angioplasty (PTA) balloon cathe
Sponsors
Sahajanand Medical Technologies Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Patient with documented diagnosis of peripheral arterial disease in SFA and/or PA classified as Rutherford class 3-5 3. Lesion(s) in SFA and/or PA suitable for endovascular treatment, scheduled to be treated with Peripherics paclitaxel-coated PTA balloon catheter according to Instructions For Use (IFU) Allowed lesion location: Lesion location starts =1 cm below the common femoral bifurcation and terminates distally =2 cm below the tibial plateau AND =1 cm above the origin of the Tibioperoneal (TP) trunk. 4. Target lesion(s) must either be de-novo or non-stented re-stenotic lesion(s). If the target lesion(s) is re-stenotic, the prior PTA must have been done more than 30 days prior-index procedure 5. Target lesion(s) can be treated with available Peripherics paclitaxel-coated PTA balloon catheter’s size matrix per the current IFU 6. Patient provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review Board (IRB) for the site 7. Patient agrees to comply with the protocol-mandated follow-up procedures and visits 8. At least one native artery with direct outflow artery to the foot
Exclusion criteria
Exclusion criteria: 1. Life expectancy of less than 1 year 2. Patient is currently participating in another investigational drug or device study that has not reached its primary endpoint yet 3. Patient is pregnant or planning to become pregnant during the course of the study 4. Known allergy to concomitant medication, paclitaxel, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant, or thrombolytic medications 5. Patient with any medical condition that would make him/her inappropriate for treatment with Peripherics paclitaxel-coated PTA balloon catheter as per the current IFU or in the opinion of the Investigator 6. Known inadequate distal outflow or planned future treatment of vascular disease distal to the target lesion 7. Evidence of aneurysm or acute thrombus in the target vessel(s) 8. Previously implanted stent in target lesion(s) 9. Previous procedure with drug-coated balloons in the target vessel(s) within 6 months prior to index procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from Major Adverse Events (MAE) Freedom from MAE defined as, a composite of freedom from all-cause mortality, freedom from major target limb amputation, and freedom from clinically driven target lesion revascularization (CD-TLR)Timepoint: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Freedom from Major Adverse Events 2. Primary patency. Primary patency defined as freedom from CD-TLR and freedom from restenosis as determined by duplex ultrasound 3. All-cause mortality 4. Major target limb amputation 5. CD-TLR 6. Change in mean Ankle Brachial Index (ABI) compared to the pre-procedure 7. Improvement in Rutherford classification compared to the pre-procedure 8. Amputation-free survival (AFS) including major, minor, and overall AFS 9. Walking Impairment Questionnaire (WIQ) 10. Device success 11. Technical success 12. Procedural Success 13. Quality of Life Assessment by VascuQoL-6Timepoint: 3 months, 6 months and 12 months 6 months and 12 months 30 days, 3 months, 6 months and 12 months 30 days, 3 months, 6 months and 12 months 30 days, 3 months, 6 months and 12 months 30 days, 3 months, 6 months and 12 months 30 days, 3 months, 6 months and 12 months 30 days, 3 months, 6 months and 12 months 30 days, 3 months, 6 months and 12 months Immediate Upon Procedure Immediate Upon Procedure Immediate Upon Procedure 30 days, 3 months, 6 months and 12 months | — |
Countries
India
Contacts
Public ContactDr P C Gupta
CARE Hospitals
Outcome results
None listed