Clinical trial NCT04280029: SELUTION SLR™ 014 In-stent Restenosis
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Restenosis
Keywords: In-stent restenosis
Drug Eluting Balloon
Coronary
Lead sponsor: M.A. Med Alliance S.A.
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
name: Cordis Corporation
First posted: 2020-02-21
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Target Lesion Failure
timeFrame: 12 months post-index procedure
Secondary outcomes:
measure: In-segment minimal luminal diameter (MLD)
timeFrame: at 12 months
measure: Device success
timeFrame: at 12 months
measure: Lesion Success
timeFrame: at 12 months
measure: Procedure Success
timeFrame: at 12 months
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Thornton
country: United States
facility: ClinRe 001-001
state: Colorado
city: Washington
country: United States
facility: MedStar Heart Institute
state: District of Columbia
city: Jacksonville
country: United States
facility: University of Florida Health
state: Florida
city: Miami
country: United States
facility: Baptist Cardiac & Vascular Institute
state: Florida
city: Atlanta
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Indianapolis
country: United States
facility: Ascension St Vincents Heart Center
state: Indiana
city: Wichita
country: United States
facility: Cardiovascular Research Institute of Kansas
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Centre, Harvard Medical School
state: Massachusetts
city: Kalamazoo
country: United States
facility: Ascension Borgess Heart Institute
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
city: Southfield
country: United States
facility: Ascension St John Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Manchester
country: United States
facility: Manchester Catholic Medical Center
state: New Hampshire
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers, Robert Wood Johnson Medical School
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital & Heart Center
state: New York
city: Greensboro
country: United States
facility: Moses H. Cone Memorial Hospital
state: North Carolina
city: Raleigh
country: United States
facility: NC Heart and Vascular Research, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Integris
state: Oklahoma
city: Harrisburg
country: United States
facility: UPMC Pinnacle Health
state: Pennsylvania
city: Hershey
country: United States
facility: Pennsylvania State University Milton S. Hershey Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Lifespan Cardiovascular Institute
state: Rhode Island
city: Nashville
country: United States
facility: HCA Centennial
state: Tennessee
city: Dallas
country: United States
facility: Baylor Scott & White
state: Texas
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White
state: Texas
city: Richmond
country: United States
facility: HCA Chippenham/VA Cardiovascular Specialists
state: Virginia
city: Hasselt
country: Belgium
facility: HartCentrum Hasslet, Jessa Ziekenhuis
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
state: SP
city: São Paulo
country: Brazil
facility: Instituto do Coração - São Paulo University
state: SP
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Dijon
country: France
facility: Clinique Valmy
city: Massy
country: France
facility: Hôpital privé Jacques Cartier
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Toulouse
country: France
facility: CHU Toulouse Rangueil
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
city: Milano
country: Italy
facility: Instituto Clinico Humanitas Milan
city: Padova
country: Italy
facility: Center Azienda Ospedaliero Universitaria de Padova
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, Academic Medical Centre
state: AZ
city: Utrecht
country: Netherlands
facility: UMC Utrecht
state: CX
city: Groningen
country: Netherlands
facility: UMCG
state: GZ
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Donald E Cutlip, MD
role: PRINCIPAL_INVESTIGATOR
References: