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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02900274
Other study ID # AAG-O-H-1502E
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2016
Est. completion date December 2020

Study information

Verified date January 2021
Source B. Braun Melsungen AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to assess the safety and efficacy of the Multi-LOC® peripheral stent system to treat de novo and restenotic lesions (no in-stent restenosis (ISR), no restenosis post drug coated balloon (DCB) after flow limiting plain old balloon angioplasty (POBA) and/or DCB dilatations in the superficial femoral artery (SFA) and popliteal segments (P1, P2 & P3)


Description:

This study is an non-randomized, prospective, multi-center, non-interventional study (registry, for Germany: §23b MPG)


Recruitment information / eligibility

Status Completed
Enrollment 353
Est. completion date December 2020
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Willingness to treat flow-limiting dissections/recoil after plain old balloon angioplasty (POBA)/drug coated balloon (DCB) interventions - Patients in Rutherford classes 2 through 5 - Patients eligible for peripheral revascularization by means of percutaneous transluminal angioplasty (PTA) and stenting - Patients must be at least 18 years of age - Patient with a life expectance of at least 12 months - Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in the following study protocol - Patients must agree to undergo at least the 6-month clinical follow-up - Patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial, e.g. balloon angioplasty by means of other suitable stent devices. Patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document. - Lesions with unsatisfying angiographic results due to recoil and/or dissections after POBA/DCB interventions - Infra-inguinal lesions in the superficial femoral artery (SFA) and popliteal segments (P1,P2 & P3) reference vessel diameters between 4 and 7.0 mm, lesion length suitable for the release of at least 2 Stent (up to 6) segments implanted with a minimum inter-stent distance of 1 cm - Diameter stenosis pre-procedure must be larger or equal to 70% - Vessels must have adequate distal run-off with at least one vessel to the foot or with collaterals in the calf supplying sufficient flow to the foot. (Lesions separated by less than 2 cm are considered as one lesion) Exclusion Criteria: - Patient not suitable for revascularization by interventional means

Study Design


Related Conditions & MeSH terms


Intervention

Device:
VascuFlex Multi-LOC®
Multi-LOC® peripheral stent system for bailout stenting after Plain Old Balloon Angioplasty (POBA) or Drug Coated Balloon (DCB) Angioplasty

Locations

Country Name City State
Germany Diakonissenkrankenhaus Mannheim Mannheim

Sponsors (2)

Lead Sponsor Collaborator
B. Braun Melsungen AG Deaconess Hospital Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary target lesion revascularization target lesion revascularization surgical & interventional 6 months
Secondary pain free walking distance pain free walking distance < 3 weeks, 6 months, 12 months
Secondary maximum walking distance maximum walking distance < 3 weeks, 6 months, 12 months
Secondary target lesion revascularization target lesion revascularization 12 months
Secondary procedural success procedural success to pass and treat the target lesion immediately after Multi-LOC implantation (within the first 30 minutes)
Secondary ankle brachial index ankle brachial index < 3 weeks, 6 months, 12 months
Secondary patency rates patency rates observed using non-invasive Duplex ultrasound 6 and 12 months
Secondary Rutherford classification Rutherford classification baseline, < 3 weeks, 6 months, 12 months
Secondary Rutherford classification shift difference in Rutherford classification compared to previous time point < 3 weeks, 6 months, 12 months
Secondary amputation rate rate of major and minor amputations 6 and 12 months
Secondary quality of life assessment quality of life assessment through validates CRF's 6 and 12 months
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