Coronary Restenosis
Conditions
Keywords
In-stent restenosis, Drug Eluting Balloon, Coronary
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.
Interventions
DEVICESELUTION SLR 014 DEB
The SELUTION Sustained Limus Release (SLR)™ 014 drug-eluting balloon (DEB) catheter is a combination product consisting of a standard percutaneous transluminal angioplasty (PTA) balloon catheter coated with a drug (Sirolimus).
DEVICEStandard of Care
POBA or FDA-approved commercially available -limus eluting DES
Sponsors
Iqvia Pty Ltd
Cordis US Corp.
M.A. Med Alliance S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Lesion Failure (TLF) | 12 months post-index procedure |
Secondary
| Measure | Time frame |
|---|---|
| Procedure Success | Index Procedure |
| Composite Safety Endpoint | Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up |
| Device success | Index Procedure |
| Lesion Success | Index Procedure |
| All-cause Mortality | Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up |
| Cardiovascular Mortality | Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up |
| MI | Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up |
| Clinically driven TLR, all TLR | Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up |
| Clinically driven TVR, all TVR, non-TVR | Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up |
| TLF | Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up |
| TVF | Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up |
| Bleeding | Prior to discharge, at 1, 6, and 12 months |
| Net adverse clinical events | Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up |
| Binary angiographic restenosis | 12 months |
| In-stent percent diameter stenosis | 12 months |
| In-segment percent diameter stenosis | 12 months |
| In-stent LLL | 12 months |
| In-segment LLL | 12 months |
| In-stent MLD | 12 months |
| In-segment MLD | 12 months |
| OCT assessment of neointimal hyperplasia, neo-atherosclerosis, and stent malapposition | 12 months |
| Stent Thrombosis | Prior to discharge, at 1, 6, and 12 months and annually thereafter through 5 years follow-up |
Other
| Measure | Time frame |
|---|---|
| Cardiac Biomarker Elevations | Peri-Procedural |
Countries
Belgium, Brazil, Canada, France, Italy, Netherlands, United States
Outcome results
None listed