SELUTION SLR™ 014 In-stent Restenosis

  • STATUS
    Recruiting
  • End date
    Sep 23, 2027
  • participants needed
    418
  • sponsor
    M.A. Med Alliance S.A.
Updated on 23 April 2022
aspirin
everolimus
myocardial infarction
angina pectoris
unstable angina
infarct
ticagrelor
ischemia
non-target
in stent restenosis

Summary

Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial.

Subjects with previous bare-metal or drug-eluting coronary stent will be randomized 1:1 to treatment with either the SELUTION SLR™ DEB or SOC to include contemporary DES (zotarolimus-eluting stents and everolimus-eluting stents only) or non-DEB BA. A maximum of 418 randomized subjects will be included. Subjects will be followed for 5 years post-intervention. Primary endpoint will be target lesion failure (TLF) determined at 12-month clinical follow-up.

Description

Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial.

Subjects with previous bare-metal or drug-eluting coronary stent and qualifying evidence for ISR will be screened per the protocol inclusion and exclusion criteria to achieve a maximum of 418 randomized subjects (includes 5% allowance for loss to follow-up). Eligible subjects will be randomized 1:1 to treatment with either the SELUTION SLR™ DEB or SOC to include contemporary DES (zotarolimus-eluting stents and everolimus-eluting stents only) or non-DEB BA. A maximum of 20% of patients randomized to SOC will be treated with BA.

Randomization will be stratified by DES or bare-metal stent (BMS) ISR and whether there has been previous repeat stenting of target lesion. Subjects with > 2 previous repeat stent procedures involving the target lesion will be excluded.

The study will test for noninferiority of DEB versus SOC and additionally noninferiority of DEB vs DES.

Primary endpoint will be target lesion failure (TLF) determined at 12-month clinical follow-up.

After initial randomized treatment subjects in the SOC group may receive DEB (including SELUTION SLR™) treatment for recurrent clinical restenosis requiring a repeat target lesion revascularization (TLR) (i.e. after the study primary endpoint has been failed).

A subset of subjects (120 subjects including the first 60 randomized in the United States (US) and first 60 randomized in Europe who receive successful study treatment) will undergo planned angiographic follow-up at 12-13 months after completion of primary endpoint clinical follow-up/assessment.

At 12-13 months, and after clinical primary endpoint has been assessed, a subset of the angiographic follow-up cohort (~60) will also undergo planned optical coherence tomography (OCT) follow-up, 30 United States (US) and 30 Europe.

Details
Condition Coronary Restenosis
Treatment Control, SELUTION SLR™ DEB
Clinical Study IdentifierNCT04280029
SponsorM.A. Med Alliance S.A.
Last Modified on23 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject age is ≥ 18 years or minimum legal age as required by local regulations
Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure
Documented stable or unstable angina including non-ST-elevation MI or functional testing demonstrating ischemia
Subject is eligible for dual antiplatelet therapy (DAPT) treatment with aspirin plus either, Clopidogrel, Prasugrel, or Ticagrelor
Life expectancy >1 year in opinion of investigator
Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations
Angiographic Inclusion Criteria
Target lesion is within a previously placed BMS or DES and does not extend > 5.00 mm beyond proximal or distal edge
Target lesion is < 36 mm in length
Target lesion has diameter stenosis of > 50% and < 100% with distal flow at least Thrombolysis in Myocardial Infarction (TIMI) 2
RVD is ≥ 2.00 mm and ≤ 4.50 mm
Target lesion is within a native coronary artery or major branch
Up to two (2) non-target lesions in non-target vessels may be treated, but successful percutaneous coronary Intervention (PCI) must be completed before treatment of target lesion

Exclusion Criteria

Known hypersensitivity or allergy to Sirolimus or other pharmacologic agents required for the procedure
ST-elevation myocardial infarction (STEMI) within 30 days
Planned treatment of additional lesions in target vessel or > two (2) non-target lesions within non-target vessels during index procedure
Planned treatment of lesion involving bifurcation or aorto-ostial location
Target lesion has undergone > two (2) prior stent implant procedures (including the initial index procedure, i.e., > two (2) layers of stent are present at any segment of target lesion)
Any previous brachytherapy of the target vessel
Previous PCI of the target vessel within 30 days
Planned PCI of a non-target vessel within 30 days of randomization
Planned use of atherectomy (rotational, orbital, or laser) device. Use of cutting or scoring balloon is allowed
History of active peptic ulcer or gastrointestinal bleeding within prior 6 months or other inability to comply with recommended duration of DAPT
Subject is pregnant, breast-feeding, or a woman of childbearing potential who is not using appropriate contraceptives to avoid becoming pregnant
Documented left ventricular ejection fraction (LVEF) < 25%
Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up
Angiographic Exclusion Criteria
Target lesion is totally occluded or has evidence of thrombus
Target lesion is severely calcified, defined as visual calcification involving both walls of the target segment as seen on a non-contrast still image
Stent diameter <80% of RVD after high pressure stent expansion
>30% residual stenosis after pre-dilation
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