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

Completed

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT05831319
• Lead Sponsor: Biotronik AG

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.

Study Timeline

• Study First Submitted: 2023-04-14
• Study First Submitted QC: 2023-04-14
• Study First Posted: 2023-04-26
• Study Start: 2023-05-29
• Status Verified: 2024-02
• Primary Completion: 2024-06-01
• Study Completion: 2024-10-30
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Procedural success rate	Index Procedure	Combination of technical success and absence of procedural complications

Secondary Outcome Measures

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

Trial Locations

Locations (17)

University Hospital Ghent; 🇧🇪 Ghent, Belgium

vzw AZ Groeninge; 🇧🇪 Kortrijk, Belgium

ospedaliero-universitaria Senese; 🇮🇹 Sienna, Italy

LKH Univ.-Klinikum Graz, Ambulanz für Angiologie; 🇦🇹 Graz, Austria

OLV Ziekenhuis Aalst; 🇧🇪 Aalst, Belgium

A.Z. Sint-Blasius; 🇧🇪 Dendermonde, Belgium

Ziekenhuis Oost Limburg; 🇧🇪 Genk, Belgium

Hopital Paris Saint Joseph; 🇫🇷 Paris, France

Karolinen-Hospital, Klinikum Arnsberg; 🇩🇪 Arnsberg, Germany

Sank Gertrauden-Krankenhaus; 🇩🇪 Berlin, Germany

Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Germany

Semmelweis University Hospital; 🇭🇺 Budapest, Hungary

Policlinico Abano Terme; 🇮🇹 Abano Terme, Italy

Azienda Usl Toscana sud est; 🇮🇹 Arezzo, Italy

Hospital General de Guadalajara; 🇪🇸 Guadalajara, Spain

Ospedale Regionale di Lugano; 🇨🇭 Lugano, Switzerland

KS Winterthur; 🇨🇭 Winterthur, Switzerland