I70.25
Conditions
Interventions
Group 1: Patients undergoing phoenix atherectomy for clinical reasons.
Sponsors
GRN Klinik Weinheim
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: PAD patients with claudication or critical limb ischemia.
Exclusion criteria
Exclusion criteria: 1. Fontaine Stages I or IIa. 2. Acute limb-threatening ischemia 3. Candidates requiring surgical revascularization 4. Creatinine clearance <30 mL/min. 5. Platelet count <100x109/L. 6. Anemia with Hb<10.0 g/dL. 7. History of or condition associated with increased bleeding Risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Procedural success (i.e. residual stenosis <25% after atherectomy and adjacent treatment), 2. clinical success (i.e. achievement of at least one grade improvement in the Rutherford class at 1 month of follow-up) and 3. Long-term clinical success (i.e. achievement of at least one grade improvement in the Rutherford class at 1-5 years of follow-up). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. safety endpoints such as perforation, dissection or embolization during the atherectomy procedure. 2. Clinically driven target vessel revascularization (TVR) at 1 month of follow-up. 3. Long-term clinically driven target vessel revascularization (TVR) at 1-5 yrs. of follow-up. | — |
Countries
Germany
Contacts
Public ContactGrigorios Korosoglou
GRN Klinik Weinheim
Outcome results
None listed