Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05946629
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2023-06-30
Brief Title:
SELUTION 4 De Novo Small Vessel IDE Trial
Sponsor:
MA Med Alliance SA
Organization:
MA Med Alliance SA
Study Overview
Official Title:
A Prospective Randomized Single-Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR 014 PTCA Drug Eluting Balloon in the Treatment of Subjects With De Novo Coronary Lesions in Small Vessels
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 200 mm to 275 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
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
Detailed Description:
Prospective randomized controlled single-blind multicenter clinical trial
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
Subjects who present with chronic coronary syndrome CCS unstable angina or stabilized non-ST elevation myocardial infarction NSTEMI with an indication for percutaneous coronary intervention PCI with planned intervention for de novo lesions in small coronary vessels RVD 200 mm to 275 mm and meeting all eligibility criteria will be randomized 11 to treatment of the identified target lesion with either the SELUTION SLR 014 PTCA DEB or contemporary DES
Randomized Cohort
Intervention DEB Strategy Subjects randomized to the SELUTION SLR 014 PTCA DEB arm will receive lesion preparation according to the 3rd drug coated balloon DCB consensus optimal balloon angioplasty with adjunct treatment using high-pressure balloon intravascular lithotripsy laser rotational or orbital atherectomy cutting or scoring balloon at the discretion of the operator as needed to reduce diameter stenosis to 30 Subjects with lesions that are then best treated by provisional stenting flow-limiting dissection residual stenosis 30 will receive a DES instead of the SELUTION DEB but remain in the SELUTION DEB group intention to treat analysis The DEB should not be used after DES implant
Control DES Subjects randomized to the DES arm will receive treatment using any FDA approved limus-based DES as per standard institutional practice
Angiographic Substudy
The angiographic substudy is a parallel registry consisting of up to 30 additional consecutive subjects meeting all eligibility criteria treated with the SELUTION DEB recruited at select study sites These subjects will undergo angiography at 12 months post-procedure Clinical follow-up will not extend beyond 12 months in this cohort
Pharmacokinetic pK Substudy
The pKsubstudy is a parallel registry consisting of up to 20 additional consecutive subjects meeting all eligibility criteria treated with the SELUTION DEB recruited at select study sites This study will be conducted under an approved substudy protocol and will include blood draws at regular intervals to characterize the pK plasma profile of sirolimus
Primary Endpoint
Target lesion failure TLF 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
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
Subjects who present with chronic coronary syndrome CCS unstable angina or stabilized non-ST elevation myocardial infarction NSTEMI with an indication for percutaneous coronary intervention PCI with planned intervention for de novo lesions in small coronary vessels RVD 200 mm to 275 mm and meeting all eligibility criteria will be randomized 11 to treatment of the identified target lesion with either the SELUTION SLR 014 PTCA DEB or contemporary DES
Randomized Cohort
Intervention DEB Strategy Subjects randomized to the SELUTION SLR 014 PTCA DEB arm will receive lesion preparation according to the 3rd drug coated balloon DCB consensus optimal balloon angioplasty with adjunct treatment using high-pressure balloon intravascular lithotripsy laser rotational or orbital atherectomy cutting or scoring balloon at the discretion of the operator as needed to reduce diameter stenosis to 30 Subjects with lesions that are then best treated by provisional stenting flow-limiting dissection residual stenosis 30 will receive a DES instead of the SELUTION DEB but remain in the SELUTION DEB group intention to treat analysis The DEB should not be used after DES implant
Control DES Subjects randomized to the DES arm will receive treatment using any FDA approved limus-based DES as per standard institutional practice
Angiographic Substudy
The angiographic substudy is a parallel registry consisting of up to 30 additional consecutive subjects meeting all eligibility criteria treated with the SELUTION DEB recruited at select study sites These subjects will undergo angiography at 12 months post-procedure Clinical follow-up will not extend beyond 12 months in this cohort
Pharmacokinetic pK Substudy
The pKsubstudy is a parallel registry consisting of up to 20 additional consecutive subjects meeting all eligibility criteria treated with the SELUTION DEB recruited at select study sites This study will be conducted under an approved substudy protocol and will include blood draws at regular intervals to characterize the pK plasma profile of sirolimus
Primary Endpoint
Target lesion failure TLF 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None