No registrations found.
ID
Source
Brief title
Health condition
Peripheral arterial disease
Critical Limb ischemia
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Primary patency: freedom from clinically driven target lesion revascularization (CD-TLR) or a significant restenosis or occlusion on imaging.
- Limb salvage: freedom from major amputations (above the ankle).
Secondary outcome
- Procedural success: a residual diameter stenosis of the target lesion ≤ 30%.
- TLR: any repeat angioplasty/bypass/thrombolysis performed on the target lesion.
- 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.
- Minor amputations: below the ankle.
- Wound healing: based on Rutherford and WIfI classifications.
- Mortality: all cause mortality and the causes of death.
- Complications:
> Major adverse cardiac events (MACE): myocardial infarction, stroke, death.
> Major adverse limb events (MALE): target lesion revascularization (including thrombolysis) and major amputations.
Background summary
Rationale: The prevalence of peripheral arterial disease (PAD) is still rising. The end stage of PAD is critical limb ischemia (CLI) and is associated with high amputation- and mortality rates and low quality of life. CLI typically presents as crural or pedal arterial pathology. Despite international guidelines, there is still clinical variation in the treatment of CLI.
Objective: To investigate the best endovascular treatment modality in patients with CLI based on arterial pathology below the knee
Study design: A prospective multi-center cohort study.
Study population: Patients (≥ 18 years) with CLI based on arterial pathology below the knee.
Main study endpoints: The primary endpoints are limb salvage and primary patency. Limb salvage is defined as freedom from major amputations, i.e. amputations above the ankle. Primary patency is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and a significant restenosis on imaging.
Nature and extent of burden: No additional actions are required and no additional risks are taken by included patients. This study will not influence patient care.
Study objective
New endovascular techniques, such as stents or drug-coated devices, demonstrate superior (patency and limb salvage) outcomes compared to conventional plain old balloon angioplasty (POBA) for critical limb ischemia (CLI) patients based on arterial pathology below the knee.
Study design
6 weeks, 6 months, 12 months, 24 months
Intervention
An endovascular intervention on the below the knee arteries can imply plain old balloon angioplasty (POBA) with or without additional treatment modalities, such as vessel preparation devices, stenting or drug-coated devices.
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9192 |
| Other | METc VUmc : 2020.0609 |