Efficacy of the SeQuent®Please in the Treatment of De-novo Stenoses Versus Taxus™Liberté™ (PEPCAD-DEBonly)

University Hospital, Saarland

Status and phase

Terminated

Phase 3

Conditions

Coronary De-novo Stenoses

Treatments

Device: Taxus™Liberté™ (Paclitaxel eluting stent)

Device: SeQuent®Please (Paclitaxel coated balloon)

Study type

Interventional

Funder types

Other

Identifiers

NCT01084408

Pac 14

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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