Dutch Critical Limb Ischemia Registry

THRILLER Registry

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON25441

Enrollment

1000

Registered

2021-01-07

Start date

2021-02-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral arterial disease Critical Limb ischemia

Interventions

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

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
- 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

Measure	Time frame
- 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.	—

Measure

Time frame

- 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.

—

Contacts

Public ContactMichael Nugteren

UMC Utrecht

M.J.Nugteren-4@umcutrecht.nl0625226813

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)