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

NCT ID: NCT05831319

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 380 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-29
• Study Completion Date: 2024-10-30

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.

Conditions

Peripheral Arterial Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Above the knee (ATK) group

Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau)

No interventions assigned to this group

Below the knee (BTK) group

Target lesions involve arteries below the tibial plateau

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deloose Koen, Dr

Role: STUDY_CHAIR

AZ Saint Blasius, Dendermonde, Belgium

Locations

LKH Univ.-Klinikum Graz, Ambulanz für Angiologie

Graz, , Austria

Ziekenhuis Oost Limburg

Genk, Genk, Belgium

OLV Ziekenhuis Aalst

Aalst, , Belgium

A.Z. Sint-Blasius

Dendermonde, , Belgium

University Hospital Ghent

Ghent, , Belgium

vzw AZ Groeninge

Kortrijk, , Belgium

Hopital Paris Saint Joseph

Paris, , France

Universitätsklinikum Tübingen

Tübingen, Tübingen, Germany

Karolinen-Hospital, Klinikum Arnsberg

Arnsberg, , Germany

Sank Gertrauden-Krankenhaus

Berlin, , Germany

Semmelweis University Hospital

Budapest, , Hungary

Policlinico Abano Terme

Abano Terme, Abano Terme, Italy

Azienda Usl Toscana sud est

Arezzo, Arezzo, Italy

ospedaliero-universitaria Senese

Siena, , Italy

Hospital General de Guadalajara

Guadalajara, , Spain

Ospedale Regionale di Lugano

Lugano, Lugano, Switzerland

KS Winterthur

Winterthur, , Switzerland

Countries

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

Other Identifiers

C2201

Identifier Type: -

Identifier Source: org_study_id