Evaluation of Standard of Care Practices, Procedural Outcomes and In-hospital Complications of Peripheral Endovascular Procedures

Peripheral Arterial Disease Clinical Trial

— BIO-OSCAR SOC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05831319
• Other study ID #: C2201
• Status: Recruiting
• Start date: May 29, 2023
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: Biotronik AG
• Contact: Helene Kuissu, PharmD
• Phone: +41 79 808 2147
• Email: adhoc-pvi-clinical-team[@]mscdigitaloffice.onmicrosoft.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: July 2024
• Est. primary completion date: May 29, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
Austria	LKH Univ.-Klinikum Graz, Ambulanz für Angiologie	Graz
Belgium	OLV Ziekenhuis Aalst	Aalst
Belgium	A.Z. Sint-Blasius	Dendermonde
Belgium	Ziekenhuis Oost Limburg	Genk
France	Hopital Paris Saint Joseph	Paris
Germany	Karolinen-Hospital, Klinikum Arnsberg	Arnsberg
Germany	Sank Gertrauden-Krankenhaus	Berlin
Germany	Universitätsklinikum Tübingen	Tübingen
Hungary	Semmelweis University Hospital	Budapest
Italy	Policlinico Abano Terme	Abano Terme
Italy	Azienda Usl Toscana sud est	Arezzo
Spain	Hospital General de Guadalajara	Guadalajara
Switzerland	Ospedale Regionale di Lugano	Lugano
Switzerland	KS Winterthur	Winterthur

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Hungary,  Italy,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural success rate	Combination of technical success and absence of procedural complications	Index Procedure
Secondary	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
Secondary	Rate of target lesion bailout stenting	Stented target lesion	Index Procedure
Secondary	Stented length	Stented length	Index Procedure
Secondary	Rate of PTA balloon related flow-limiting dissections	PTA balloon related flow-limiting dissections	Index Procedure
Secondary	Rate of distal embolization	Distal embolization	Index Procedure
Secondary	Rate of target vessel rupture	Target vessel rupture	Index Procedure
Secondary	Rate of target vessel perforation	Target vessel perforation	Index Procedure
Secondary	Rate of acute occlusion	Acute occlusion	Index Procedure
Secondary	Primary crossing success rate	Successfully placement of a guidewire into the distal true lumen with the primary crossing strategy	Index Procedure
Secondary	Rate of Serious Adverse Device Effects	Serious Adverse Device Effects	Index Procedure
Secondary	Non-labor resource use	Devices use	Index procedure until discharge