An interventional study of SeQuent Please ReX and Plain old balloon angioplasty (POBA) in In-stent Coronary Artery Restenosis, Coronary Artery Restenosis and In-stent Restenosis, sponsored by B. Braun Medical Inc.. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-14.
Sponsored by B. Braun Medical Inc. · Not applicable, Interventional, and Treatment
The objective of this study is to establish reasonable assurance of safety and effectiveness to support an FDA premarket approval (PMA) application for the SeQuent® Please ReX™ Drug Coated PTCA Balloon Catheter as indicated.
The investigation is a prospective, randomized, multi-center IDE study comparing the SeQuent Please ReX to plain old balloon angioplasty (POBA). The study will be conducted at up to 30 investigational sites and enroll up to 296 patients with in-stent restenosis of a metallic coronary stent who are suitable candidates for PTCA procedures. After consent and assessment of inclusion and exclusion criteria, eligible patients will be randomized to either the SeQuent Please ReX or POBA arm based on a 2:1 randomization ratio. Subjects will return for follow-up through 5 years.
97 studies on the registry are indexed under Coronary Restenosis; 9 are open to participants now.
Browse Coronary Restenosis studies →B. Braun Medical Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Symptomatic ischemic heart disease, including:
One or two ISR lesions requiring treatment
EXCLUSION CRITERIA:
Note: Bifurcation lesions are not excluded; however, the main branch should be treated per randomization, and the side branch should be treated provisionally per current standard of care.
Angiographic Exclusion Criteria:
Subjects must not meet any of the following angiographic exclusion criteria after lesion preparation:
Drug coated balloon (DCB) catheter.
Device: SeQuent Please ReX
Device: Plain old balloon angioplasty (POBA)
The SeQuent Please ReX is a conventional rapid exchange balloon tip catheter with a drug-coated balloon (DCB). The surface of the SeQuent Please ReX balloon is coated with paclitaxel, embedded in a soluble matrix (resveratrol).
Any commercially available semi-compliant PTCA balloon may be used per the investigator's discretion.
Freedom from target lesion failure (TLF)
TLF is defined as the composite of any of the following events: * Clinically-driven target lesion revascularization (TLR) * Myocardial infarction (MI; not clearly attributable to a nontarget vessel) * Cardiovascular death
Time frame: 12 months post-procedure
Late lumen loss (LLL)
Assessed on the first 100 subjects reaching 9-month follow-up (angiographic cohort). Minimum lumen diameter (MLD) assessed at follow-up angiography minus the MLD assessed immediately after the index procedure. MLDs are measured by qualitative comparative analysis.
Time frame: 9 months post-procedure
All death
Death of subject.
Time frame: 12 months post-procedure and annually thereafter to study completion
Cardiovascular death
Death resulting from cardiovascular causes.
Time frame: 12 months post-procedure and annually thereafter to study completion
Myocardial infarction (MI)
Not clearly attributable to a nontarget vessel
Time frame: 12 months post-procedure and annually thereafter to study completion
Major adverse cardiac events (MACE)
Defined as the composite of all death, clinically-driven TLR, and MI
Time frame: 12 months post-procedure and annually thereafter to study completion
Stent thrombosis
Early, late, or very late; ARC category of definite or probable
Time frame: 12 months post-procedure and annually thereafter to study completion
Clinically-driven target lesion revascularization (TLR)
Target lesion revascularization is defined as a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Time frame: 12 months post-procedure and annually thereafter to study completion
Clinically-driven target vessel revascularization (TVR)
Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion.
Time frame: 12 months post-procedure and annually thereafter to study completion
Device, lesion, and procedural success
Device success defined as achievement of a final residual stenosis of ≤30% (as determined by the angiographic core lab), using the SeQuent Please ReX or control balloon. Lesion success defined as achievement of a final residual stenosis of ≤0% (as determined by the angiographic core lab), using any device. Procedural success defined as lesion success without the occurrence of major adverse events during the procedure, where "major adverse event" is considered to be an event without the occurrence of in-hospital MI, TVR, or cardiac death.
Time frame: Post-procedure (device and lesion success) and at discharge (procedural success)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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B. Braun Medical Inc.