"All Comers" Post Market Clinical Follow-up (PMCF) With Multi-LOC for flOw liMiting Outcomes (LOCOMOTIVE Extended)

Peripheral Arterial Occlusive Disease Clinical Trial

Official title:

"All Comers" Post Market Clinical Follow-up (PMCF) With Multi-LOC for flOw liMiting Outcomes After Plain Old Balloon Angioplasty (POBA) and/or Drug Coated Balloon (DCB) Treatment in the Infra-inguinal Position With the objectiVE to Implant Multiple Stent Segments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02900274
• Other study ID #: AAG-O-H-1502E
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Occlusive Disease

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