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

Peripheral Artery Disease Clinical Trial

— SUCCESS PTA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04776434
• Other study ID #: S2020-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 8, 2021
• Est. completion date: December 31, 2028

Study information

• Verified date: October 2023
• Source: M.A. Med Alliance S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 723
• Est. completion date: December 31, 2028
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Germany	Klinikum Hochsauerland	Arnsberg

Sponsors (1)

Lead Sponsor	Collaborator
M.A. Med Alliance S.A.

Country where clinical trial is conducted

Germany, 

Outcome

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