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
- Conditions
- in-stent restenosisreocclusion of coronary vessels10011082
- Registration Number
- NL-OMON54574
- Lead Sponsor
- MedAlliance LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Subjects must meet all of the following clinical criteria to participate in the
trial:
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 MI (NSTEMI) (biomarkers stabilized or down
trending) with an indication for PCI and planned intervention.
4. Subject is eligible for DAPT treatment with aspirin plus either,
Clopidogrel, Prasugrel, or Ticagrelor. Note: Subjects who require continued
oral anticoagulant therapy may 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.
Subjects must meet all the following imaging criteria to participate in the
trial:
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 > 50% and <= 99% by visual estimate.
6. 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. 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 more than 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 the 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.
Imaging exclusion criteria:
1. Target lesion is 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint for effectiveness is TLF rate at 12 months post-index<br /><br>procedure. TLF is defined as all cardiac death, target vessel<br /><br>myocardial infarction (SCAI definition), or clinically driven TLR. </p><br>
- Secondary Outcome Measures
Name Time Method