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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05831319
Other study ID # C2201
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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)

Study Design


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
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