I70.21
Conditions
Interventions
Group 1: Subjects with symptoms of intermittent claudication and/or critical limb ischemia (Rutherford class 2-3-4-5-6) with angiographic evidence of iliaco-arterial stenosis will be consecutively scr
Sponsors
Medizinische Universitätsklinik III
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Age = 18 years or minimum age as required by local regulations. • Subject with documented diagnosis of peripheral arterial disease (PAD) in the iliac arteries. • Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis within the target vessels with a minimum lesion length of 0,5 cm including bilateral disease if both limbs are treated within 35 days. • Positive diagnostic indication for PTA in addition to stent implantation in accordance with the Instructions for Use (IFU) of the Jaguar stent. • Female subjects of childbearing potential must have a negative pregnancy test = 7 days before enrollment. • Signed and dated Patient Informed Consent (PIC) form. • Ability and willingness to comply with the clinical investigation plan. • Life expectancy,in the investigator's opinion, of at least 12 months.
Exclusion criteria
Exclusion criteria: • High probability of non-adherence to CIP follow-up requirements. • Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion). • Lesion within or adjacent to an aneurysm • Plan for surgical procedure within 30 days after the study procedure (except for bilateral target limb treatment). • Known allergies or sensitivities to heparin, aspirin, other anti- coagulant/anti-platelet therapies, and/or paclitaxel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: Any re-intervention within the target lesion (s) due to symptoms or drop of ABI >30% or > 0.15 when compared to post-index procedure baseline ABI. NOTE: TLRs which are performed on non-symptomatic subjects or based only on diagnostic imaging procedures do not meet the definition of clinically- driven TLR. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. MAEs at 6 and 12 months. ( MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.) 2. All-cause mortality at 6 and 12 months. 3. Clinically-driven TLR at 6 and 12 months. 4. Clinically-driven TVR at 6 and 12 months. (Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of = 20% or > 0.15 when compared to post-index procedure baseline ABI.) 5. TLR at 6 and 12 months months. 6. TVR at 6 and 12 months. 7. Major target limb amputation at 6 and 12 months. 8. Time to all-cause mortality through 12 months post-index procedure. 9. Primary sustained clinical improvement at 6 and 12 months. (Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.) 10. Device success (Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP).) 11. Procedural successh (Procedural success is defined as residual stenosis of = 50% (non-stented subjects) or = 30% (stented subjects) by visual estimate.) 12. Clinical success (Clinical success is defined as procedural success without complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge.) | — |
Countries
Germany
Contacts
Public ContactChristian Erbel
Medizinische Universitätsklinik III
Outcome results
None listed