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

NCT ID: NCT01084408

Last Updated: 2021-03-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-01
• Study Completion Date: 2013-03-01

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.

Conditions

Coronary De-novo Stenoses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sequent®Please

Group Type: ACTIVE_COMPARATOR

SeQuent®Please (Paclitaxel coated balloon)

Intervention Type: DEVICE

PCI of de-novo lesions

Taxus™Liberté™

Group Type: ACTIVE_COMPARATOR

Taxus™Liberté™ (Paclitaxel eluting stent)

Intervention Type: DEVICE

PCI of de-novo lesions

Interventions

SeQuent®Please (Paclitaxel coated balloon)

PCI of de-novo lesions

Intervention Type: DEVICE

Taxus™Liberté™ (Paclitaxel eluting stent)

PCI of de-novo lesions

Intervention Type: DEVICE

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Saarland

OTHER

Sponsor Role: lead

Responsible Party

Bruno Scheller

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruno Scheller, Prof. Dr. med

Role: PRINCIPAL_INVESTIGATOR

Uniklinikum des Saarlandes

Locations

Klinik für Kardiologie, Angiologie und Konservative Intensivtherapie Klinikum Ernst von Bergmann

Postdam, Brandenburg, Germany

Medizinisches Versorgungszentrum

Hamburg, , Germany

Countries

Germany

Other Identifiers

Pac 14

Identifier Type: -

Identifier Source: org_study_id