Clinical trial NCT05831319: Evaluation of Standard of Care Practices, Procedural Outcomes and In-hospital Complications of Peripheral Endovascular Procedures
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2023-04-26
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who have PAD with target lesion(s) located in the femoral, popliteal and/or infrapopliteal artery are eligible for the study. Up to 380 subjects will be enrolled in approximately 12 investigational sites in Europe.

Brief summary: 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.

Detailed description: The study will enroll consecutive eligible subjects who have peripheral artery disease (PAD) requiring endovascular treatment of de-novo and restenotic atherosclerotic lesions in femoral, popliteal and infrapopliteal arteries.

The purpose of this prospective, multicenter, observational European Study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications of endovascular peripheral interventions for treatment of lesions in the femoral, popliteal and infrapopliteal arteries.

Eligibility criteria: 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.

Exclusion Criteria:

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)

Primary outcomes:
measure: Procedural success rate
timeFrame: Index Procedure
Secondary outcomes:
measure: Procedure technical success rate
timeFrame: Index Procedure
measure: Rate of target lesion bailout stenting
timeFrame: Index Procedure
measure: Stented length
timeFrame: Index Procedure
measure: Rate of PTA balloon related flow-limiting dissections
timeFrame: Index Procedure
measure: Rate of distal embolization
timeFrame: Index Procedure
measure: Rate of target vessel rupture
timeFrame: Index Procedure
measure: Rate of target vessel perforation
timeFrame: Index Procedure
measure: Rate of acute occlusion
timeFrame: Index Procedure
measure: Primary crossing success rate
timeFrame: Index Procedure
measure: Rate of Serious Adverse Device Effects
timeFrame: Index Procedure
measure: Non-labor resource use
timeFrame: Index procedure until discharge
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH Univ.-Klinikum Graz, Ambulanz für Angiologie
city: Aalst
country: Belgium
facility: OLV Ziekenhuis Aalst
city: Dendermonde
country: Belgium
facility: A.Z. Sint-Blasius
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Kortrijk
country: Belgium
facility: vzw AZ Groeninge
city: Paris
country: France
facility: Hopital Paris Saint Joseph
city: Arnsberg
country: Germany
facility: Karolinen-Hospital, Klinikum Arnsberg
city: Berlin
country: Germany
facility: Sank Gertrauden-Krankenhaus
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Budapest
country: Hungary
facility: Semmelweis University Hospital
city: Abano Terme
country: Italy
facility: Policlinico Abano Terme
city: Arezzo
country: Italy
facility: Azienda Usl Toscana sud est
city: Sienna
country: Italy
facility: ospedaliero-universitaria Senese
city: Guadalajara
country: Spain
facility: Hospital General de Guadalajara
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano
city: Winterthur
country: Switzerland
facility: KS Winterthur
Study officials:
affiliation: AZ Saint Blasius, Dendermonde, Belgium
name: Deloose Koen, Dr
role: STUDY_CHAIR
References: