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SELUTION 4 De Novo Small Vessel IDE Trial

ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.A. Med Alliance S.A.

About this trial

Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of 2.00 mm to 2.75 mm, in support of a pre-market approval (PMA) application to the United States (US) FDA.

The Study will enroll up to 910 randomized subjects, up to 30 subjects in a parallel angiographic substudy, and up to 20 subjects in a parallel pharmacokinetic (pK) substudy, at up to 80 sites in the US, Canada, Brazil, Japan and Europe. A minimum of 50% of the subjects will be enrolled in the US.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical Inclusion Criteria

Subject is ≥ 18 years (or the minimum legal age as required by local regulations).

Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before the procedure or are using a contraceptive device or drug.

Subject presents with chronic coronary syndromes [CCS] (manifest as documented angina or positive functional testing), unstable angina or stabilized non-ST elevation myocardial infarction (NSTEMI) (biomarkers stabilized or down trending) with an indication for PCI and planned intervention.

Disqualifiers

Clinical Exclusion Criteria

Subject with known hypersensitivity or allergy to Sirolimus or its analogues.

Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically instable.

Subject with history of ST-elevation myocardial infarction (STEMI) within 30 days of the index procedure.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PCI with SELUTION SLR DCB

    Device

    After target lesion pre-dilatation and preparation , a SELUTION SLR 014 PTCA DEB study device should be selected with nominal diameter equal to the RVD of the target lesion (1:1 ratio) and length that allows approximately 2.00 mm longer than the proximal and distal edges of the target lesion (defined as the proximal and distal extent of predilation). If IVUS is performed to assess RVD, and DEB upsizing is deemed clinically necessary for optimal results, a maximum nominal DEB diameter of 3.0 mm is permitted. The SELUTION SLR 014 PTCA DEB should then be delivered, positioned in and deployed per instructions per use. The balloon should be inflated for 60 seconds provided that the patient can tolerate this duration. The minimum inflation time is 30 seconds.

  • PCI with FDA approved "-limus" DES

    Device

    For subjects randomized to the control group (DES), the treating physician will choose an FDA cleared DES and follow lesion preparation and stent deployment according to the Instructions per use (IFU) and institutional practices. The DES should be sized per IFU with respect to the vessel RVD. The use of IVUS or OCT is encouraged to guide optimal stent placement and assess final results. After DES deployment, additional balloon inflations should be performed as needed to obtain \< 30% residual diameter stenosis and resolve proximal or distal edge dissections greater than or equal to NHLBI grade B.

Treatment groups

960 Participants
are divided into 2 treatment groups
Group A: SELUTION SLR 014 PTCA DEBExperimental treatment 1 intervention
Group B: Control TreatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Target lesion failure (TLF)

Target lesion failure (TLF) is defined as the composite of cardiac death, target-vessel myocardial infarction (MI) or clinically-driven target lesion revascularization (TLR) at 12 months. MI includes spontaneous (Type 1) MI using the 4th Universal Definition of Myocardial Infarction (UDMI) and peri-procedural MI using the Society for Cardiac Angiography and Intervention (SCAI) definition.

Time frame
12 months
2

PK Sub-study Primary Endpoint 1

PK parameters of C(max)

Time frame
6 months
3

PK Sub-study Primary Endpoint 2

PK parameters of T(max)

Time frame
6 months
4

PK Sub-study Primary Endpoint 3

PK parameters of AUC(last)

Time frame
6 months

Secondary outcomes

1

Secondary Endpoint 1

Composite of all-cause mortality, target vessel MI or clinically driven target lesion revascularization

Time frame
12 months
2

Secondary Endpoint 2

Lesion success, defined as attainment of \< 30% residual stenosis of target lesion using any percutaneous method

Time frame
Up to 7 days
3

Secondary Endpoint 3

Procedure success, defined as attainment of \< 30% residual stenosis of the target lesion using the assigned study device only without the occurrence of in-hospital major adverse cardiac events (MACE), composite of all-cause death, MI or any clinically-driven TLR.

Time frame
Up to 7 days
4

Secondary Endpoint 4

Composite safety endpoint, defined as the patient-oriented composite of any death, any MI (spontaneous or peri-procedural), or any repeat revascularization.

Time frame
Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years

Other outcomes

1

PK Sub-Study Secondary Endpoint 1

If calculations are valid, additional PK parameter of AUC(inf).

Time frame
6 months
2

PK Sub-Study Secondary Endpoint 2

If calculations are valid, additional PK parameter of Cl.

Time frame
6 months
3

PK Sub-Study Secondary Endpoint 3

If calculations are valid, additional PK parameter of Vz.

Time frame
6 months
4

PK Sub-Study Secondary Endpoint 4

If calculations are valid, additional PK parameter of Vss.

Time frame
6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.A. Med Alliance S.A.

Lead sponsor

NAMSA

Collaborator

Cordis US Corp.

Collaborator

Source ClinicalTrials.gov
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