CompletedNo phase
Evaluation of Standard of Care Practices, Procedural Outcomes and In-hospital Complications of Peripheral Endovascular Procedures
Key facts
- Who runs it
- Biotronik AG
- Where
- Austria, Belgium, France, Germany, Hungary, Italy, Spain, and Switzerland17 sites in 8 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 380 people enrolled
- Started
- 29 May 2023
- Ended
- 30 Oct 2024
- Type of study
- Observational, 2 groups
- Record updated
- 1 November 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- Subject ≥18 years old
- Subject has provided written informed consent
- Subject has Rutherford classification 2 to 6
- Reference vessel diameter ≥2 and ≤7 mm
- Target lesion(s) has stenosis >70% by visual assessment
- 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
- Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau)
- At least 1 below-knee artery patent to the ankle
- 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:
- Target lesions involve arteries below the tibial plateau
- 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
Who cannot take part
- Subject not suitable for receiving endovascular procedures of lower limb arteries
- Prior planned major amputation in the target limb (above the ankle)
- Subject with previous bypass surgery of target vessel
- 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
- Subject currently enrolled in another investigational device, biologic, or drug trial in which the primary endpoint has not yet been reached
- History of any open surgical procedure within the past 30 days
- Subject has a single target lesion that involves both ATK and BTK segment
- Subject under dialysis
- Subject lacking capacity to provide informed consent
- Subject under judicial protection, tutorship, or curatorship (for France only)
This trial has no sites in United States.
It has sites in 8 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Above the knee (ATK) group
Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau)
- Below the knee (BTK) group
Target lesions involve arteries below the tibial plateau
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Record updated
- 1 November 2024