Informations générales (source: ClinicalTrials.gov)
A Prospective, Multicenter, Observational Study Evaluating Standard of Care Practices, Procedural Outcomes, and In-hospital Complications of Endovascular Procedures for Treatment of Atherosclerotic Lesions in the Infrainguinal Arteries (BIO-OSCAR SOC)
Observational
Biotronik AG (Voir sur ClinicalTrials)
mai 2023
juillet 2024
29 juin 2024
Significant advances in dedicated materials and techniques along with increased operator
experience led to a significant increment in procedural success rate of peripheral
endovascular interventions, exceeding 90% in expert hands with reported low procedural
complication rates. However, there are still lack of data on procedural outcomes,
in-hospital complications, and resource utilization on treatment of (complex) lesions in
the femoral, popliteal and infrapopliteal artery in the real-world condition in Europe.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Subject ≥18 years old
2. Subject has provided written informed consent
3. Subject has Rutherford classification 2 to 6
4. Reference vessel diameter ≥2 and ≤7 mm
5. Target lesion(s) has stenosis >70% by visual assessment
6. Multiple consecutive single lesions with a healthy segment(s) of ≤ 3cm in-between
the lesions will be considered one lesion.
For Above the knee (ATK) group
7. Target lesions located in the superficial femoral artery or popliteal arteries
(above the tibial plateau)
8. At least 1 below-knee artery patent to the ankle
9. Successful treatment of inflow iliac stenosis to the target lesion. Inflow lesion
stenosis can be treated during the same procedure as per local standard of care.
For Below the knee (BTK) group:
10. Target lesions involve arteries below the tibial plateau
11. Successful treatment of inflow vessel (from ipsilateral iliac to the target lesion)
resulting in ≤30% residual stenosis with no evidence of embolization or significant
complications.
1. Subject ≥18 years old
2. Subject has provided written informed consent
3. Subject has Rutherford classification 2 to 6
4. Reference vessel diameter ≥2 and ≤7 mm
5. Target lesion(s) has stenosis >70% by visual assessment
6. Multiple consecutive single lesions with a healthy segment(s) of ≤ 3cm in-between
the lesions will be considered one lesion.
For Above the knee (ATK) group
7. Target lesions located in the superficial femoral artery or popliteal arteries
(above the tibial plateau)
8. At least 1 below-knee artery patent to the ankle
9. Successful treatment of inflow iliac stenosis to the target lesion. Inflow lesion
stenosis can be treated during the same procedure as per local standard of care.
For Below the knee (BTK) group:
10. Target lesions involve arteries below the tibial plateau
11. Successful treatment of inflow vessel (from ipsilateral iliac to the target lesion)
resulting in ≤30% residual stenosis with no evidence of embolization or significant
complications.
1. Subject has a single target lesion that involves both ATK and BTK segment.
2. Subject not suitable for receiving endovascular procedures of lower limb arteries
3. Prior planned major amputation in the target limb (above the ankle)
4. Subject with previous bypass surgery of target vessel.
5. History of any open surgical procedure within the past 30 days.
6. Planned vascular surgery procedure within the next 30 days after the ATK and/or BTK
procedure on the target limb. Note: The inflow vessels can be treated on the day of
the procedure
7. Subject under dialysis
8. Subject currently enrolled in another investigational device, biologic, or drug
trial in which the primary endpoint has not yet been reached
9. Subject lacking capacity to provide informed consent
10. Subject under judicial protection, tutorship, or curatorship (for France only)