Efficacy Study of Paclitaxel-eluting Balloon, -Stent vs. Plain Angioplasty for Drug-eluting Stent Restenosis

Study Overview
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Brief Summary
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The purpose of this randomized study is to determine which treatment option, either paclitaxel-eluting balloon, paclitaxel-eluting stent or plain balloon angioplasty is the most effective in the treatment of restenosis after implantation of Limus-eluting stents, (LES).

Detailed Description
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The use of drug-eluting stents (DES) has led to a drastic reduction of restenosis rates compared to bare metal stents (BMS), but 5% to 10% of patients receiving DES are still in need of revascularization of the treated vessel. Two important families of drugs are used for stent coating: paclitaxel belonging to the taxane family, and the limus-family such as sirolimus, everolimus, zotarolimus, biolimus A9 and pimecrolimus. Data regarding the optimal treatment of in-DES-restenosis is very limited. Implanting a new DES for in-DES-restenosis has been reported to be associated with re-restenosis rates as high as 43%. Several recent well published studies have shown a substantial reduction of restenosis using paclitaxel-eluting balloons (PEB) for de-novo lesions and BMS-restenotic lesions. The objective of this randomized trial is to assess the hypothesis, that PEB are non-inferior to paclitaxel-eluting-stents (PES) for restenosis in limus-eluting-stents (LES), and both, PEB and PES, are superior to plain angioplasty in patients with restenosis after initial LES implantation.

Official Title
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Randomized Trial of Paclitaxel-Eluting Balloon, Paclitaxel-Eluting Stent and Plain Balloon Angioplasty for Restenosis in -Limus-Eluting Coronary Stents

Conditions
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Heart Disease, Ischemia, Restenosis

Intervention / Treatment
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* Device: Taxus stent
* Device: SeQuent Please
* Device: Conventional Balloon Catheter


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 or her/his legally-authorized representative 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, stainless steel, cobalt, chrome. 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel-eluting stent<br>Paclitaxel-eluting stent (Taxus) | Device: Taxus stent<br>* Implantation of paclitaxel-eluting stent<br>|
| Active Comparator: Plain Balloon<br>plain balloon angioplasty | Device: Conventional Balloon Catheter<br>* Ryuijin, Trek<br>|
| Experimental: Paclitaxel-eluting balloon<br>SeQuent Please | Device: SeQuent Please<br>* Dilation with SeQuent Please (paclitaxel-eluting balloon)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent in-segment diameter stenosis at follow-up angiography |  | 6-8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-segment minimal luminal diameter |  | 6-8 months | 
| In-segment binary angiographic restenosis |  | 6-8 months | 
| Combined incidence of death or myocardial infarction |  | 1 and 2 years | 
| Incidence of thrombosis |  | 1 and 2 years |