Dutch Critical Limb Ischemia Registry
- Conditions
- Peripheral arterial diseaseCritical Limb ischemia
- Registration Number
- NL-OMON25441
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 1000
Inclusion Criteria
Patients = 18 years with critical limb ischemia (CLI) who undergo an endovascular intervention of the below the knee (BTK) segment.
- Patients treated in the P2 or P3 segments of the popliteal artery are included.
- Patients who undergo a failed attempt of endovascular revascularization (''no option'' critical ischemia) will also be included.
- Patients who underwent previous (endovascular) surgery in the same segment or who undergo simultaneous revascularization in other arterial segments will also be included.
Exclusion Criteria
- Patients who undergo an endovascular intervention in the P1 segment of the popliteal artery or more proximal segment.
- Patients who don't meet the inclusion criteria
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Primary patency: freedom from clinically driven target lesion revascularization (CD-TLR) or a significant restenosis or occlusion on imaging. <br>- Limb salvage: freedom from major amputations (above the ankle).
- Secondary Outcome Measures
Name Time Method - Procedural success: a residual diameter stenosis of the target lesion = 30%. <br>- TLR: any repeat angioplasty/bypass/thrombolysis performed on the target lesion. <br>- Limb based patency (LBP): patency of the ‘’target arterial path’’ (TAP): starts at the origin of the superficial femoral artery and provides in-line flow to the foot. <br>- Minor amputations: below the ankle. <br>- Wound healing: based on Rutherford and WIfI classifications.<br>- Mortality: all cause mortality and the causes of death. <br>- Complications: <br>> Major adverse cardiac events (MACE): myocardial infarction, stroke, death. <br>> Major adverse limb events (MALE): target lesion revascularization (including thrombolysis) and major amputations.