Evaluation of Standard of Care Practices, Procedural Outcomes and In-hospital Complications of Peripheral Endovascular Procedures (BIO-OSCAR SOC)

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease

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.

• Study Type: Observational
• Enrollment (Actual): 380

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • LKH Univ.-Klinikum Graz, Ambulanz für Angiologie
• Belgium
  • Aalst, Belgium
    • OLV Ziekenhuis Aalst
  • Dendermonde, Belgium
    • A.Z. Sint-Blasius
  • Genk, Belgium, 3600
    • Ziekenhuis Oost Limburg
  • Ghent, Belgium, 9000
    • University Hospital Ghent
  • Kortrijk, Belgium, 8500
    • Vzw Az Groeninge
• France
  • Paris, France
    • Hopital Paris Saint Joseph
• Germany
  • Arnsberg, Germany
    • Karolinen-Hospital, Klinikum Arnsberg
  • Berlin, Germany
    • Sank Gertrauden-Krankenhaus
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen
• Hungary
  • Budapest, Hungary
    • Semmelweis University Hospital
• Italy
  • Abano Terme, Italy, 35031
    • Policlinico Abano Terme
  • Arezzo, Italy, 52100
    • Azienda Usl Toscana sud est
  • Sienna, Italy, 53100
    • ospedaliero-universitaria Senese
• Spain
  • Guadalajara, Spain
    • Hospital General de Guadalajara
• Switzerland
  • Lugano, Switzerland, 6962
    • Ospedale Regionale di Lugano
  • Winterthur, Switzerland
    • KS Winterthur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success rate	Combination of technical success and absence of procedural complications	Index Procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure technical success rate	successful crossing and achievement of a final residual diameter stenosis of ≤30% of the treated target lesion on the procedural completion angiography	Index Procedure
Rate of target lesion bailout stenting	Stented target lesion	Index Procedure
Stented length	Stented length	Index Procedure
Rate of PTA balloon related flow-limiting dissections	PTA balloon related flow-limiting dissections	Index Procedure
Rate of distal embolization	Distal embolization	Index Procedure
Rate of target vessel rupture	Target vessel rupture	Index Procedure
Rate of target vessel perforation	Target vessel perforation	Index Procedure
Rate of acute occlusion	Acute occlusion	Index Procedure
Primary crossing success rate	Successfully placement of a guidewire into the distal true lumen with the primary crossing strategy	Index Procedure
Rate of Serious Adverse Device Effects	Serious Adverse Device Effects	Index Procedure
Non-labor resource use	Devices use	Index procedure until discharge

Collaborators and Investigators

• Sponsor: Biotronik AG
• Investigators: Study Chair: Deloose Koen, Dr, AZ Saint Blasius, Dendermonde, Belgium

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2023
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: C2201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The individual participant data (IPD) is not yet drafted. No decision is taken to share it yet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No