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

NCT05831319 | Completed

• 1 other identifier: C2201
• Study Type: observational
• Target: 380
• Locations: 8 countries
• Sites: 17

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Procedural success rate

  Combination of technical success and absence of procedural complications

  Index Procedure

Secondary Outcomes (11)

• Procedure technical success rate

  Index Procedure

• Rate of target lesion bailout stenting

  Index Procedure

• Stented length

  Index Procedure

• Rate of PTA balloon related flow-limiting dissections

  Index Procedure

• Rate of distal embolization

  Index Procedure

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subject ≥18 years old
• Subject has provided written informed consent
• Subject has Rutherford classification 2 to 6
• Reference vessel diameter ≥2 and ≤7 mm
• Target lesion(s) has stenosis \>70% by visual assessment
• 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
• Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau)
• At least 1 below-knee artery patent to the ankle
• 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:
• Target lesions involve arteries below the tibial plateau
• 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.

You may not qualify if:

• Subject has a single target lesion that involves both ATK and BTK segment.
• Subject not suitable for receiving endovascular procedures of lower limb arteries
• Prior planned major amputation in the target limb (above the ankle)
• Subject with previous bypass surgery of target vessel.
• History of any open surgical procedure within the past 30 days.
• 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
• Subject under dialysis
• Subject currently enrolled in another investigational device, biologic, or drug trial in which the primary endpoint has not yet been reached
• Subject lacking capacity to provide informed consent
• Subject under judicial protection, tutorship, or curatorship (for France only)

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (17)

LKH Univ.-Klinikum Graz, Ambulanz für Angiologie

Graz, Austria

Location

Ziekenhuis Oost Limburg

Genk, Genk, 3600, Belgium

Location

OLV Ziekenhuis Aalst

Aalst, Belgium

Location

A.Z. Sint-Blasius

Dendermonde, Belgium

Location

University Hospital Ghent

Ghent, 9000, Belgium

Location

vzw AZ Groeninge

Kortrijk, 8500, Belgium

Location

Hopital Paris Saint Joseph

Paris, France

Location

Universitätsklinikum Tübingen

Tübingen, Tübingen, 72076, Germany

Location

Karolinen-Hospital, Klinikum Arnsberg

Arnsberg, Germany

Location

Sank Gertrauden-Krankenhaus

Berlin, Germany

Location

Semmelweis University Hospital

Budapest, Hungary

Location

Policlinico Abano Terme

Abano Terme, Abano Terme, 35031, Italy

Location

Azienda Usl Toscana sud est

Arezzo, Arezzo, 52100, Italy

Location

ospedaliero-universitaria Senese

Siena, 53100, Italy

Location

Hospital General de Guadalajara

Guadalajara, Spain

Location

Ospedale Regionale di Lugano

Lugano, Lugano, 6962, Switzerland

Location

KS Winterthur

Winterthur, Switzerland

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Deloose Koen, Dr

  AZ Saint Blasius, Dendermonde, Belgium

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 26, 2023
• Study Start: May 29, 2023
• Primary Completion: June 1, 2024
• Study Completion: October 30, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-02

Locations

ES (1); FR (1); AU (1); HU (1); CH (2); DE (3); IT (3); BE (5)