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SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study (SUCCESS PTA)

Primary Purpose

Peripheral Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB)
Sponsored by
M.A. Med Alliance S.A.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject age is ≥ 18 years
  • Subject is able and willing to provide informed consent
  • Subject is suitable for treatment with a MedAlliance SELUTION SLR DEB according to the current Instruction for use.

Exclusion Criteria:

  • In the opinion of the treating investigator the subject has a life expectancy of less than 12 months
  • In the opinion of the treating investigator the subject is unlikely to comply with the study follow-up regime

Sites / Locations

  • Klinikum HochsauerlandRecruiting

Outcomes

Primary Outcome Measures

Clinically Driven Target Lesion Revascularization
The primary endpoint will be freedom from Clinically Driven Target Lesion Revascularisation (CD-TLR) at 1-year post-intervention.

Secondary Outcome Measures

Device Success
Successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure.
Procedure success
Device success and residual stenosis ≤50% at the end of the procedure.
Clinical success
Procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion or TLR) prior to discharge.
Major Adverse Limb Events (MALE) composite endpoint
Severe limb ischemia leading to an intervention or major vascular amputation (above the ankle).
Major Cardiac Events Major Cardiac Events
MI, Stroke, Cardiovascular death
Death
All-cause, cardiac, device related, procedure related
TLR
Number of Target Lesion Revascularizations
TVR
Number of Target Vessel Revascularizations
Time to first CD-TLR
Time to first Clinically Driven Target Lesion Revascularization
Target limb revascularization
Number of Target limb revascularizations
Thrombosis at the target site
Number of Thrombosis at the target site
Amputation
Number of Amputations
Rutherford Classification score
Change in Rutherford Classification score from baseline (Scale from 0 to 6, higher score means worse outcome.
Ankle Brachial Index (ABI)
Change in ankle brachial index (ABI) from baseline
Pedal pulse
Presence of Pedal pulse
Wound status if applicable
location, size, infection, status, Wound, Ischemia and Foot Infection (WIfI) classification system score
Kawarada Classification score
Change from baseline to end of procedure to assess change in severity of Pedal Artery Disease

Full Information

First Posted
February 10, 2021
Last Updated
May 26, 2023
Sponsor
M.A. Med Alliance S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04776434
Brief Title
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Acronym
SUCCESS PTA
Official Title
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.A. Med Alliance S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB).
Detailed Description
Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB). This study will capture data from the use of the SELUTION SLR according to its approved labelling. Each indication for use will have a specific data sets in addition to generic data sets that are common across all indications. Patients will be followed for 5 years post-procedure to obtain safety and efficacy data. A health economic analysis will be made comparing data between countries within the study and to published data for existing treatment options. Generic and disease specific Patient Reported Outcome Measures (PROMs) will be used to measure the impact of the intervention on the overall health status of patients. Imaging data collection for patients whose standard of care includes imaging follow-up will be captured and analysed. Data will be collected from any subject who receives a CE marked device for treatment of a peripheral (i.e. non-cardiovascular) vascular lesion. Data analysis will be stratified by lesion location.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
722 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB)
Intervention Description
This study will capture data from the use of the SELUTION SLR according to its approved labelling.
Primary Outcome Measure Information:
Title
Clinically Driven Target Lesion Revascularization
Description
The primary endpoint will be freedom from Clinically Driven Target Lesion Revascularisation (CD-TLR) at 1-year post-intervention.
Time Frame
1 year after treatment
Secondary Outcome Measure Information:
Title
Device Success
Description
Successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure.
Time Frame
At end of procedure
Title
Procedure success
Description
Device success and residual stenosis ≤50% at the end of the procedure.
Time Frame
At end of procedure
Title
Clinical success
Description
Procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion or TLR) prior to discharge.
Time Frame
At discharge after procedure
Title
Major Adverse Limb Events (MALE) composite endpoint
Description
Severe limb ischemia leading to an intervention or major vascular amputation (above the ankle).
Time Frame
At discharge after procedure and 1, 6, 12, 24, 36, 48 and 60 months
Title
Major Cardiac Events Major Cardiac Events
Description
MI, Stroke, Cardiovascular death
Time Frame
At 1, 6, 12, 24, 36,48, 60 months
Title
Death
Description
All-cause, cardiac, device related, procedure related
Time Frame
At 1, 6, 12, 24, 36, 48, 60 months
Title
TLR
Description
Number of Target Lesion Revascularizations
Time Frame
At 1, 6, 12, 24, 36, 48, 60 months
Title
TVR
Description
Number of Target Vessel Revascularizations
Time Frame
At 1, 6, 12, 24, 36, 48, 60 months
Title
Time to first CD-TLR
Description
Time to first Clinically Driven Target Lesion Revascularization
Time Frame
up to 60 months
Title
Target limb revascularization
Description
Number of Target limb revascularizations
Time Frame
At 1, 6, 12, 24, 36, 48, 60 months
Title
Thrombosis at the target site
Description
Number of Thrombosis at the target site
Time Frame
At 1 month
Title
Amputation
Description
Number of Amputations
Time Frame
up to 60 months
Title
Rutherford Classification score
Description
Change in Rutherford Classification score from baseline (Scale from 0 to 6, higher score means worse outcome.
Time Frame
At 6, 12, 24, 36, 48, 60 months
Title
Ankle Brachial Index (ABI)
Description
Change in ankle brachial index (ABI) from baseline
Time Frame
At 6, 12 months only
Title
Pedal pulse
Description
Presence of Pedal pulse
Time Frame
6, 12 months only
Title
Wound status if applicable
Description
location, size, infection, status, Wound, Ischemia and Foot Infection (WIfI) classification system score
Time Frame
6, 12 months only
Title
Kawarada Classification score
Description
Change from baseline to end of procedure to assess change in severity of Pedal Artery Disease
Time Frame
At end of procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject age is ≥ 18 years Subject is able and willing to provide informed consent Subject is suitable for treatment with a MedAlliance SELUTION SLR DEB according to the current Instruction for use. Exclusion Criteria: In the opinion of the treating investigator the subject has a life expectancy of less than 12 months In the opinion of the treating investigator the subject is unlikely to comply with the study follow-up regime
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tamara Solaja
Phone
+31643600231
Email
tsolaja@medalliance.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rana Saitta
Phone
+41223637890
Email
rsaitta@medalliance.com
Facility Information:
Facility Name
Klinikum Hochsauerland
City
Arnsberg
ZIP/Postal Code
59759
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Lichtenberg
Email
m.lichtenberg@klinikum-hochsauerland.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study

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