In This SectionTexas Health Research & Education Institute
Disease or Condition
Treatment of Subjects w/ De Novo Occluded/Stenotic or Re-occluded/Restenotic Lesions of the Superficial Femoral or Popliteal Arteries using a Paclitaxel-Coated or Bare Percutaneous Transluminal Angioplasty Balloon Catheter (Cardiology)
The purpose of this study is to investigate if the treatment of narrowed leg blood vessels with the CVI Paclitaxel Coated Balloon is safe and beneficial.
Subjects with symptomatic leg ischemia, requiring treatment of the SFA and/or popliteal artery.
Male or non-pregnant female greater than or equal to 18 years of age.
Subject is willing to provide informed consent and comply with the required follow up visits, testing schedule, and medication regimen.
Subject will not undergo other prior vascular interventions within 14 days before and/or planned 30 days after the protocol treatment.
Life expectancy >1 year.
Rutherford classification of 2, 3 or 4.
Additionally, Study Subjects must fulfill the following angiographic criteria at angiogram assessment:
De novo or restenotic lesion (except for in-stent restenotic lesion) >70% within the SFA and/or popliteal artery in a single limb.
A single lesion which is =3 cm and =14 cm in length (by visual estimation). NOTE: Tandem lesions can be treated. A tandem lesion is defined as two distinct lesions with 3 cm or less of healthy vessel separating the two diseased areas. The total cumulative length of the tandem lesions, including the healthy vessel, must not exceed 14 cm.
The lesion must be treatable by no more than two (2) devices.
Lesion is located >2 cm from any stent if the vessel was previously stented.
Successful wire crossing of lesion. The guidewire advancement should not be indicative of the presence of fresh thrombus in the lesion.
Target reference vessel diameter =4 mm and =6 mm (by visual estimation).
Subject’s inflow artery is patent, free from significant lesion stenosis (=50% stenosis is considered significant) as confirmed by angiography. Treatment of a target lesion is acceptable after successful treatment of inflow artery lesion(s). NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis <30% without death or major vascular complication.
Subject presents in the index limb with at least one patent (less than 50% stenosis) tibio-peroneal run-off vessel confirmed by baseline angiography or prior Magnetic Resonance angiography or Computed Tomography angiography. NOTE: treatment of outflow disease is NOT permitted.
Pregnant or lactating females.
Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries.
Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.
Subject is participating in another investigational device or drug study.
History of hemorrhagic stroke within 3 months.
Previous or planned surgical or interventional procedure within 14 days before or 30 days after index procedure.
Prior vascular surgery of the target lesion.
Rutherford classification of 0, 1, 5 or 6.
Treatment of lesions in the contralateral limb with the CVI Paclitaxel-coated PTA Catheter.
Use of the CVI Paclitaxel-coated PTA Catheter in other than a single treatment session.
Subject with any of the following angiographic criteria should be excluded:
Lesion length is <3 cm or >14 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured.
Known inadequate distal outflow.
Significant inflow disease.
Acute or sub-acute thrombus in target vessel.
Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy).
Treatment of the contralateral limb during the same procedure or within 30 days of the study procedure.
Presence of prohibitive calcification that precludes adequate PTA treatment.