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 cathet
Sponsors
Sahajanand Medical Technologies Limited
Eligibility
Inclusion criteria
Inclusion criteria: Rutherford Clinical Category 3-5 Significant stenosis or occlusion of one or two native artery(s) below the tibial plateau and above the tibiotalar joint appropriate for angioplasty per operator visual assessment Patient is willing to provide informed consent, and is willing to comply with the protocol required follow-up visits and recommended medication regimen
Exclusion criteria
Exclusion criteria: Life expectancy of less than 1-year Lesions and/or occlusions located or extending into the popliteal artery or below the ankle joint space. Inflow lesion or occlusion in the ipsilateral Iliac, superficial femoral artery (SFA), popliteal arteries with a length equal to or above 15 cm. Patient is currently participating in another investigational drug or device study that has not reached its primary endpoint yet. Known allergy to concomitant medication, paclitaxel, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant, or thrombolytic medications. Patient with any medical condition that would make him/her inappropriate for treatment with Peripherics paclitaxel-coated balloon catheter as per the current IFU or in the opinion of the Investigator Planned major amputation above the ankle of target limb, or any other planned major surgery within 30 days post-procedure Patients with neurotrophic ulcers, heel pressure ulcers or calcaneal ulcers with a risk for major amputation Evidence of aneurysm or acute thrombus in the target vessel(s) Previously implanted stent in target lesion(s) Previous procedure with drug-coated balloons in the target vessel(s) within 6 months prior to index procedure Presence of concentric calcification that precludes adequate vessel preparation as per the current IFU Patients confined to bed that are completely non-ambulatory
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Adverse Limb Events (MALE) with perioperative all-cause deathTimepoint: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Adverse Events (MAE)Timepoint: 12 months | — |
Countries
India
Contacts
Public ContactDr Varinder Singh Bedi
Sir Ganga Ram Hospital
Outcome results
None listed