Trial of a Novel Paclitaxel-coated Balloon With Citrate Excipient for Restenosis in -Limus Analogue DES

Study Overview
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Brief Summary
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Hypothesis: Angioplasty with a novel paclitaxel-coated balloon (PCB; Agent, Boston Scientific) with citrate-based excipient will be non-inferior to conventional paclitaxel-coated balloon with iopromide excipient (PCB) for the treatment of coronary restenosis after implantation of limus-analogue drug-eluting stents (DES)

Detailed Description
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The optimal management of patients presenting with drug-eluting stent (DES) restenosis remains unclear. Data from recent randomized clinical trials have suggested that angioplasty with drug-coated balloons (DCB) is associated with excellent clinical outcomes. However, as the effectiveness of DCB devices depends critically on the specific composition of its matrix coating there may be important differences in clinical performance between different DCB devices. The prospective, non-randomized, single arm, historical-control ISAR-DESIRE 3A trial is designed to test that hypothesis that angioplasty with a novel paclitaxel-coated balloon with citrate-based excipient (Agent PCB, Boston Scientific) will be non-inferior to a conventional paclitaxel-coated balloon with iopromide excipient (SeQuent Please PCB, B. Braun; data from ISAR-DESIRE 3) for the treatment of coronary restenosis after implantation of limus-analogue drug-eluting stents (DES). The key inclusion criteria are patients with symptoms and/or objective signs of ischemia, restenosis at the site of previous limus-analogue DES implantation and written, informed consent. The primary endpoint is in-segment percent diameter stenosis (%DS) at 6-8 month follow-up angiography. Sample size calculation is based on a non-inferiority analysis: %DS of 35% after Both PCB, non-inferiority margin of 7% absolute, 1-sided α-level of 0.05 and power of 80% resulting in 102 patients per group. To account for possible FU losses 125 patients in total will be enrolled.

Official Title
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Trial of a Novel Paclitaxel-coated Balloon With Citrate Excipient for Restenosis in -Limus Analogue Drug-eluting Coronary Stents

Conditions
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Coronary Restenosis

Intervention / Treatment
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* Device: PCB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% restenosis after prior implantation of LES in native coronary vessels. Written, informed consent by the patient for participation in the study. In women with childbearing potential a negative pregnancy test is mandatory. Exclusion Criteria: Age < 18 years Cardiogenic shock Acute ST-elevation myocardial infarction within 48 hours from symptom onset. Target lesion located in the left main trunk or bypass graft. Target lesion located in small vessel (vessel size < 2.0 mm) Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance. Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min) Contraindications to antiplatelet therapy, paclitaxel Pregnancy (present, suspected or planned) or positive pregnancy test. Previous enrollment in this trial. Patient's inability to fully comply with the study protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCB<br>Paclitacel-coated balloon (Agent, Boston Scientific) | Device: PCB<br>* PCB with Citrate-based excipient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-segment percent diameter stenosis (%DS) |  | at 6-8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-segment minimal lumen diameter and binary restenosis |  | at 6-8 months | 
| Composite of death or myocardial infarction |  | at 12 months | 
| Target lesion revascularization and thrombosis |  | at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Restenosis, restenosis, paclitaxel-coated balloon, drug-eluting stent, drug-coated balloon, coronary angiography