Health Condition 1: I702- Atherosclerosis of native arteriesof the extremities
Conditions
Interventions
Intervention1: Group A - IVUS + Angiography guided Femoropopliteal Endovascular Intervention: Standard Endovascular Femoropopliteal intervention guided by both IVUS and conventional angiography. IVUS
Sponsors
Jain Institute of Vascular Sciences, Bhagawan Mahaveer Jain Hospital.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age greater than or equal to 18 2. Rutherford class 3-6, 3. Lesion in Superficial femoral artery or popliteal artery confirmed by CT Angio/ MR Angio/ Duplex Ultrasound, 4. Willingness to comply with 6-month follow up, 5. Willingness and ability to give informed consent.
Exclusion criteria
Exclusion criteria: 1. Allergy to contrast media, 2. Inability to provide informed consent, 3. Acute limb ischemia, 4. Prior Ipsilateral Femoropopliteal intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Binary restenosis at 6 months, defined as greater than or equal to 50% stenosis on duplex ultrasound or on follow up imaging.Timepoint: 6 months post procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Target lesion revascularization rate at 6 months, 2. Differences in reference vessel diameter measured by IVUS vs Angiography, 3. Difference in lesion length measurement between IVUS and Angiography, 4. Frequency and type of treatment plan modifications following IVUS assessment, 5. Peri procedural complications and major adverse events (MAE) - defined as death, Major amputation, Target vessel occlusion.Timepoint: 1, 3 and 6 months | — |
Countries
India
Contacts
Public ContactDr Sumanth Raj
Jain Institue of vascular sciences, Bhagwan mahaveer jain hospital
Outcome results
None listed