Health Condition 1: I739- Peripheral vascular disease, unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Dr Varinder Singh Bedi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant, non-breastfeeding female >=18 years of age 2. Rutherford Clinical Category 3-5 3. 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 4. Patients who will be treated with at least one Peripherics paclitaxel-coated balloon catheter in below-the-knee arteries as described in the Instruction for Use (IFU) 5. 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 > 30 days prior-index procedure
Exclusion criteria
Exclusion criteria: 1. Life expectancy of less than 1-year 2. Lesions and/or occlusions located or extending into the popliteal artery or below the ankle joint space. 3. Inflow lesion or occlusion in the ipsilateral Iliac, superficial femoral artery (SFA), popliteal arteries with a length >= 15 cm. 4. Patient is currently participating in another investigational drug or device study that has not reached its primary endpoint yet 5. 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 6. Planned major amputation above the ankle of target limb, or any other planned major surgery within 30 days post-procedure 7. Previously implanted stent in target lesion(s) 8. Previous procedure with drug-coated balloons in the target vessel(s) within 6 months prior to index procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary safety endpoint: Major Adverse Limb Events (MALE) with perioperative all-cause death (POD) MALE is defined as a composite of above-ankle amputation, or major reintervention (i.e., new bypass graft, jump/interposition graft revision, or thrombectomy /thrombolysis) of the treated limb involving a BTK artery. POD is defined as all-cause death within 30 days after the index procedure. Primary efficacy endpoint: Evaluation of wound healing according to the society for vascular surgery lower extremity threatened limb classification system: risk stratification based on wound, ischemia, and foot infection (WIfI).Timepoint: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Adverse Events (MAE)Timepoint: 30 days, 2 months, 3 months, and 6 months;Primary patencyTimepoint: 6 months;All-cause mortalityTimepoint: 30 days, 2 months, 3 months, and 6 months;Major amputationTimepoint: 30 days, 2 months, 3 months, and 6 months;CD-TLRTimepoint: 30 days, 2 months, 3 months, and 6 months;Improvement in Rutherford classification compared to the pre-procedureTimepoint: 30 days, 2 months, 3 months, and 6 months;Amputation-free survival (AFS) including major, minor, and overall AFSTimepoint: 30 days, 2 months, 3 months, and 6 months;Change in mean Ankle Brachial Index (ABI) / Transcutaneous oxygen pressure (TcPO2) compared to the pre-procedureTimepoint: 30 days, 2 months, 3 months, and 6 months;Device successTimepoint: Immediately upon procedure;Technical successTimepoint: Immediately upon procedure;Procedural successTimepoint: Immediately upon discharge | — |
Countries
India
Contacts
Public ContactDr Varinder Singh Bedi
Sir Ganga Ram Hospital
Outcome results
None listed