Clinical trial NCT01084408: Efficacy of the SeQuent®Please in the Treatment of De-novo Stenoses Versus Taxus™Liberté™
Official title: Randomized Trial on the Treatment of Coronary De-novo Lesions With a Drug Eluting Stent or a Drug Coated Balloon
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Coronary De-novo Stenoses
Keywords: de-novo
coronary stenoses
PEPCAD
DEBonly
Paclitaxel
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2010-03-10
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the trial is to assess the efficacy of the Paclitaxel-coated SeQuent®Please angioplasty balloon in the treatment of stenoses in native coronary arteries compared to a drug eluting stent.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Clinical evidence of stable or unstable angina or a positive functional study
* Single, stenotic de novo lesion in a native coronary artery, type A or selected B1 (see 4.3.1.1 Definition of lesion types)
* Diameter stenosis \> 70% (visual estimate)
* Vessel diameter 2.5 - 3.5 mm
* Female patients can enter this study if they are post-menopausal for at least two years or have undergone hysterectomy or sterilization
* Signed patient informed consent form
* Patient's and treating physician's agree that the patient will return for all required post procedure follow-up assessments as defined in the clinical protocol

Exclusion Criteria:

* Left ventricular ejection fraction of \< 30%
* Visible thrombus proximal to the lesion
* Expection that treatment with devices other than PTCA will be required for this lesion.
* Stenosis is within a bypass graft
* Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel, or a sensitivity to contrast media which cannot be adequately pre-medicated
* Other medical illness (i.e. cancer, liver disease or congestive heart failure) that may require cytostatic or radiation therapy, cause the subject to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than two years).
* Acute myocardial infarction within the past 72 hours of the intended treatment (de-fined as: Q wave infarction having total creatinine kinase (CK) \>3 times the upper normal limit, or CK remains elevated above hospital normal at time of treatment)
* Chronic renal insufficiency with serum creatinine \> 2.0 mg%
* Significant gastrointestinal (GI) bleed within the past six months.
* History of bleeding diathesis or coagulopathy or will refuse blood transfusions
* Extensive peripheral vascular disease that precludes safe 6 French sheath insertion and / or requires additional anti-platelet and / or anti-coagulation treatment.
* Participating in another device or drug study within the last 6 months which may inter-fere with the interpretation of results of this study

Primary outcomes:
measure: Late lumen loss
timeFrame: 6 months
Secondary outcomes:
measure: Thrombotic occlusion of the target lesion
timeFrame: 30 days, 6, 12, 24, 60 months
measure: Revascularization of the target lesion
timeFrame: 30 days, 6, 12, 24, 60 months
measure: Myocardial infarction
timeFrame: 30 days, 6, 12, 24, 60 months
measure: Death
timeFrame: 30 days, 6, 12, 24, 60 months
measure: Combined clinical endpoint (MACE)
timeFrame: 30 days, 6, 12, 24, 60 months
Other outcomes:
Locations:
city: Postdam
country: Germany
facility: Klinik für Kardiologie, Angiologie und Konservative Intensivtherapie Klinikum Ernst von Bergmann
state: Brandenburg
city: Hamburg
country: Germany
facility: Medizinisches Versorgungszentrum
Study officials:
affiliation: Uniklinikum des Saarlandes
name: Bruno Scheller, Prof. Dr. med
role: PRINCIPAL_INVESTIGATOR
References: