"All Comers" Post Market Clinical Follow-up (PMCF) With M... | NCT02531230

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

NCT02531230

Sponsor

B. Braun Melsungen AG

Status

Completed

Last Update Posted

Oct 10, 2018Actual

Enrollment

75Actual

Phase

Not provided

Conditions

Peripheral Arterial Occlusive Disease

Interventions

VascuFlex Multi-LOC®

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Jul 2016Actual

Completion Date

Aug 2017Actual

First Submitted Date

May 29, 2015

First Submission Date that Met QC Criteria

Aug 20, 2015

First Posted Date

Aug 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2018

Last Update Posted Date

Oct 10, 2018Actual

Name	Class
Deaconess Hospital Mannheim	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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)

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Name	Type	Description	Arm Group Labels	Other Names
VascuFlex Multi-LOC®	Device	Multi-LOC® peripheral stent system for bailout stenting after Plain Old Balloon Angioplasty (POBA) or Drug Coated Balloon (DCB) Angioplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
target lesion revascularization	target lesion revascularization surgical & interventional	6 months

Secondary Outcomes

Measure	Description	Time Frame
pain free walking distance	pain free walking distance	< 3 weeks, 6 months, 12 months
maximum walking distance	maximum walking distance

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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)

Sampling Method

Probability Sample

Name	Affiliation	Role
Klaus Amendt, MD	Deaconess Hospital Mannheim	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30361959	Derived	Sigl M, Beschorner U, Zeller T, Waliszewski M, Langhoff R, Tautenhahn J, Amendt K. Focal Stenting of Complex Femoropopliteal Lesions with the Multi-LOC Multiple Stent Delivery System: 12-Month Results of the Multicenter LOCOMOTIVE Study. Cardiovasc Intervent Radiol. 2019 Feb;42(2):169-175. doi: 10.1007/s00270-018-2095-9. Epub 2018 Oct 25.