SELUTION SLR™ 014 In-stent Restenosis

Coronary Restenosis Clinical Trial

— SELUTION4ISR  

Official title:

SELUTION SLR™ 014 ISR: A Prospective Randomized Single Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Subjects With In-stent Restenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04280029
• Other study ID #: SEL-003-2019
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2020
• Est. completion date: November 2027

Study information

• Verified date: April 2024
• Source: M.A. Med Alliance S.A.
• Contact: Michelle Alamo
• Phone: 267-218-2816
• Email: michelle.alamo[@]cordis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial. Subjects with previous bare-metal stent (BMS) or DES and qualifying evidence for ISR will be screened per the protocol inclusion and exclusion criteria. Eligible subjects will be randomized 1:1 to treatment with either the SELUTION SLR™ 014 DEB or SOC to include contemporary DES (zotarolimus-eluting stents [ZES] and everolimus-eluting stents [EES] only) or BA. A maximum of 20% of patients randomized to SOC will be treated with BA. The primary endpoint will be Target Lesion Failure (TLF) at 12-months in the SOC group vs. the SELUTION SLR™ 014 DEB in all patients.

Description:

Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial will enroll up to 418 randomized subjects (including up to 60 subjects in an angiographic and optical coherence tomography [OCT] sub-study) at up to 80 sites in the United States (US), Canada, Brazil, and Europe (EU). A minimum of 50% of the subjects will be enrolled in the US. Subjects with previous bare-metal stent (BMS) or DES and qualifying evidence for ISR will be screened per the protocol inclusion and exclusion criteria. Eligible subjects will be randomized 1:1 to treatment with either the SELUTION SLR™ 014 DEB or SOC to include contemporary DES (zotarolimus-eluting stents [ZES] and everolimus-eluting stents [EES] only) or BA. A maximum of 20% of patients randomized to SOC will be treated with BA. The primary endpoint will be Target Lesion Failure (TLF) at 12-months in the SOC group vs. the SELUTION SLR™ 014 DEB group. A subset of up to 60 subjects will be enrolled in the angiographic and OCT sub-study and undergo planned angiographic and OCT follow-up within 30 days after completion of the 12-month primary endpoint clinical follow-up/assessment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 418
• Est. completion date: November 2027
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Clinical Inclusion Criteria:

1. Subject age is = 18 years or minimum legal age as required by local regulations.

2. Female subjects of childbearing potential have a negative pregnancy test = 7 days before the procedure.

3. Subject presents with chronic coronary syndrome (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 percutaneous coronary intervention (PCI) and planned intervention.

4. Subject is eligible for dual antiplatelet therapy (DAPT) treatment with aspirin plus either Clopidogrel, Prasugrel, or Ticagrelor. Note: Subjects who require continued oral anticoagulant therapy my omit aspirin at discretion of investigator.

5. Life expectancy >1 year in opinion of investigator.

6. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations. Angiographic Inclusion Criteria

1. Target lesion is within a native coronary artery or major branch.

2. Target lesion is within a previously placed BMS or DES and does not extend further than 5 mm beyond either the proximal or distal edge of the stent.

3. Up to two (2) non-target lesions in non-target vessels may be treated, but successful PCI of the non-target lesions must be completed before treatment of the target lesion. Successful treatment is defined as no greater than 30% residual stenosis by visual estimate, no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C, and Thrombolysis in Myocardial Infarction (TIMI) grade flow in the non-target lesion > 2.

4. Target lesion is = 26 mm in length.

5. Target lesion has diameter stenosis of > 50% and = 99% by visual estimate.

6. Reference vessel diameter (RVD) is = 2.00 mm and = 4.50 mm.

7. Target lesion must be successfully pre-dilated/pre-treated. Note: Successful pre-dilation/pre-treatment is defined as dilation or pre-treatment that achieves stent expansion of approximately 80% of the distal RVD (at the discretion of the investigator) based on intravascular ultrasound (IVUS)/optical coherence tomography (OCT) and no greater than 30% residual stenosis by visual estimate and no dissection greater than NHLBI type C. TIMI grade flow in the target lesion must be > 2. Note: Atherectomy and cutting balloon are permitted for pre-treatment.

Clinical Exclusion Criteria:

1. Known hypersensitivity or allergy to Sirolimus or other pharmacologic agents required for the procedure.

2. ST-elevation myocardial infarction (STEMI) within 30 days.

3. Planned treatment of additional lesions in the target vessel, or more than two (2) non-target lesions within non-target vessels, during the index procedure.

4. Target lesion is located within a bifurcation with planned treatment of side branch vessel.

5. Target lesion is the 3rd or greater stent failure (i.e., more than two [2] layers of stent are present at any segment of the target lesion).

6. Target vessel had any previous vascular brachytherapy treatment or is planned to undergo brachytherapy at index procedure.

7. Previous PCI of the target vessel within 30 days.

8. Planned PCI of a non-target vessel, or a non-target lesion in the target vessel, within 30 days of randomization.

9. Subject has chronic renal insufficiency (dialysis dependent, or glomerular filtration rate [GFR] = 30 ml/min/1.73 m² within 30 days of index procedure) or has undergone renal transplantation.

10. Subject has acute renal insufficiency confirmed by 50% increase of serum creatinine within 48 hours before procedure and/or decrease in urine output.

11. History of active peptic ulcer or gastrointestinal bleeding within prior 6 months or other inability to comply with recommended duration of DAPT.

12. Subject is pregnant, breast-feeding, or a woman of childbearing potential who is not using appropriate contraceptives to avoid becoming pregnant.

13. Documented left ventricular ejection fraction (LVEF) < 25%.

14. Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up. Angiographic Exclusion Criteria

1. Target lesion is a total occlusion or has evidence of thrombus.

2. Target lesion involves an unprotected left main.

3. Target lesion has > 30% residual stenosis by visual estimate or dissection greater than NHLBI type C after pre-dilation/pre-treatment.

Related Conditions & MeSH terms

• Coronary Restenosis

Intervention

Device:
• SELUTION SLR™ DEB
The SELUTION Sustained Limus Release (SLR)™ drug-eluting balloon (DEB) catheter is a combination product consisting of a standard percutaneous transluminal coronary angioplasty (PTCA) balloon catheter coated with a drug (Sirolimus).
• Control
POBA or FDA-approved -limus DES

Locations

Country	Name	City	State
Belgium	HartCentrum Hasslet, Jessa Ziekenhuis	Hasselt
Brazil	Hospital de Clinicas	Porto Alegre	RS
Brazil	Instituto de Cardiologia de Porto Alegre	Porto Alegre	RS
Brazil	Instituto Dante Pazzanese de Cardiologia	São Paulo	SP
Brazil	Instituto do Coração - São Paulo University	São Paulo	SP
France	Clinique Valmy	Dijon
France	Hôpital privé Jacques Cartier	Massy
France	Clinique Saint Hilaire	Rouen
France	CHU Toulouse Rangueil	Toulouse
Italy	Maria Cecilia Hospital	Cotignola
Italy	Instituto Clinico Humanitas Milan	Milano
Italy	Center Azienda Ospedaliero Universitaria de Padova	Padova
Italy	Cisanello Hospital, University of Pisa	Pisa
Netherlands	Amsterdam UMC, Academic Medical Centre	Amsterdam	AZ
Netherlands	UMCG	Groningen	GZ
Netherlands	UMC Utrecht	Utrecht	CX
United States	Atlanta VA Medical Center	Atlanta	Georgia
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	University of Maryland	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Centre, Harvard Medical School	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	The Christ Hospital	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Baylor Scott & White	Dallas	Texas
United States	Moses H. Cone Memorial Hospital	Greensboro	North Carolina
United States	UPMC Pinnacle Health	Harrisburg	Pennsylvania
United States	Pennsylvania State University Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	Ascension St Vincents Heart Center	Indianapolis	Indiana
United States	University of Florida Health	Jacksonville	Florida
United States	Ascension Borgess Heart Institute	Kalamazoo	Michigan
United States	Loma Linda University	Loma Linda	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Texas Tech University Health Sciences Center	Lubbock	Texas
United States	Manchester Catholic Medical Center	Manchester	New Hampshire
United States	Baptist Cardiac & Vascular Institute	Miami	Florida
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	Morristown Medical Center	Morristown	New Jersey
United States	HCA Centennial	Nashville	Tennessee
United States	Rutgers, Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Yale University	New Haven	Connecticut
United States	Mount Sinai Hospital	New York	New York
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Integris	Oklahoma City	Oklahoma
United States	Lifespan Cardiovascular Institute	Providence	Rhode Island
United States	The Miriam Hospital	Providence	Rhode Island
United States	NC Heart and Vascular Research, LLC	Raleigh	North Carolina
United States	HCA Chippenham/VA Cardiovascular Specialists	Richmond	Virginia
United States	St. Francis Hospital & Heart Center	Roslyn	New York
United States	Beaumont Hospital	Royal Oak	Michigan
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Ascension St John Hospital	Southfield	Michigan
United States	Baylor Scott & White	Temple	Texas
United States	ClinRe 001-001	Thornton	Colorado
United States	Harbor-UCLA Medical Center	Torrance	California
United States	MedStar Heart Institute	Washington	District of Columbia
United States	Cardiovascular Research Institute of Kansas	Wichita	Kansas
United States	Genesis Healthcare System	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
M.A. Med Alliance S.A.	Iqvia Pty Ltd

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  France,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Lesion Failure	The primary safety and efficacy endpoint is TLF at 12 months post-index procedure for SELUTION SLR 014 DEB versus SOC in all patients. TLF is defined as all cardiac death, target vessel myocardial infarction (MI) or clinically driven TLF.; 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.	12 months post-index procedure
Secondary	In-segment minimal luminal diameter (MLD)	The powered secondary endpoint will be in-segment minimal luminal diameter (MLD) at 12 months (after documented completion of 12 months of clinical follow-up) in the angiographic follow-up subset.	at 12 months
Secondary	Device success	Attainment of < 30% residual stenosis of the target lesion using the assigned study device only.	at 12 months
Secondary	Lesion Success	Attainment of < 30% residual stenosis of target lesion using any percutaneous method.	at 12 months
Secondary	Procedure Success	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), a composite of all-cause death, MI or clinically driven TLR.	at 12 months