Status:
COMPLETED
Efficacy Study of Paclitaxel-eluting Balloon, -Stent vs. Plain Angioplasty for Drug-eluting Stent Restenosis
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Conditions:
Heart Disease
Ischemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 treat...
Detailed Description
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 revascularizat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT00987324
Start Date
July 1 2009
End Date
October 1 2013
Last Update
November 21 2016
Active Locations (3)
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1
1. Med. Klinik, Klinikum rechts der Isar
Munich, Bavaria, Germany, 81675
2
Herz-Zentrum
Bad Krozingen, Germany, 79189
3
Deutsches Herzzentrum
Munich, Germany, 80636