Safety, Acute Efficacy and Long-Term Effectiveness of the Phoenix Atherectomy System in Patients with Lower Limb Ischemia. A Prospective Study.
- Conditions
- I70.25
- Registration Number
- DRKS00016708
- Lead Sponsor
- GRN Klinik Weinheim
- Brief Summary
Background: Endovascular atherectomy enables minimally invasive plaque removal in peripheral artery disease (PAD). Aims: We aimed to evaluate the safety and the long-term effectiveness of the Phoenix atherectomy for the treatment of complex and calcified lesions in PAD patients. Methods: Consecutive all-comer patients with PAD underwent the Phoenix atherectomy. Device safety in terms of perforation and distal embolisation were evaluated. Lesion calcifications were categorised by the Peripheral Arterial Calcium Scoring System (PACSS) and lesion complexity was assessed by the Transatlantic Inter-Society Consensus (TASC). Clinically driven target lesion revascularisation (TLR) was assessed. Results: A total of 558 lesions were treated in 402 consecutive patients. Clinical follow-up was available at 15.7±10.2 months for 365 (91%) patients. Of 402 patients, 135 (33.6%) had claudication, 37 (9.2%) had ischaemic rest pain and 230 (57%) exhibited ischaemic ulcerations. Lesions were mostly identified in the femoropopliteal segments (55%), followed by below-the-knee (BTK) segments (32%). Complex TASC C/D lesions and moderate to severe calcifications (PACSS score =2) were present in 331 (82%) and 323 (80%) patients, respectively. The mean lesion length was 20.6±14.3 cm. Five (1%) perforations and 10 (2%) asymptomatic embolisations occurred. Bail-out stenting was performed in 4%, 16% and 3% of patients with common femoral artery, femoropopliteal and BTK lesions, respectively. During follow-up, 5 (3.9%) patients with claudication and 52 (21.9%) patients with critical limb-threatening ischaemia (CLTI) died (hazard ratio [HR] 3.7; p<0.001). Freedom from TLR was 87.5% (112 of 128) in patients with claudication and 82.3% (195 of 237) in patients with CLTI, respectively (HR 1.8; p=0.03). Conclusions: The Phoenix atherectomy can be safely performed in patients with complex lesions with a relatively low rate of bail-out stenting and clinically acceptable TLR rates.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 500
PAD patients with claudication or critical limb ischemia.
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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Procedural success (i.e. residual stenosis <25% after atherectomy and adjacent treatment),<br>2. clinical success (i.e. achievement of at least one grade improvement in the Rutherford class at 1 month of follow-up) and <br>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 Outcome Measures
Name Time Method 1. safety endpoints such as perforation, dissection or embolization during the atherectomy procedure.<br>2. Clinically driven target vessel revascularization (TVR) at 1 month of follow-up. <br>3. Long-term clinically driven target vessel revascularization (TVR) at 1-5 yrs. of follow-up. <br>