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

Sponsor:	University Hospital, Saarland
Collaborator:	B. Braun Melsungen AG
Information provided by:	University Hospital, Saarland
ClinicalTrials.gov Identifier:	NCT01084408

Purpose

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.

Condition	Intervention	Phase
Coronary De-novo Stenoses	Device: SeQuent®Please (Paclitaxel coated balloon) Device: Taxus™Liberté™ (Paclitaxel eluting stent)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Trial on the Treatment of Coronary De-novo Lesions With a Drug Eluting Stent or a Drug Coated Balloon

Resource links provided by NLM:

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:

Late lumen loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Late lumen loss = MLD in-lesion initially - MLD in lesion after six months (after nitroglycerin in identical projections); assessment by an independent Core Lab.

Secondary Outcome Measures:

Thrombotic occlusion of the target lesion [ Time Frame: 30 days, 6, 12, 24, 60 months ] [ Designated as safety issue: No ]
Revascularization of the target lesion [ Time Frame: 30 days, 6, 12, 24, 60 months ] [ Designated as safety issue: No ]
Myocardial infarction [ Time Frame: 30 days, 6, 12, 24, 60 months ] [ Designated as safety issue: Yes ]
Death [ Time Frame: 30 days, 6, 12, 24, 60 months ] [ Designated as safety issue: Yes ]
Combined clinical endpoint (MACE) [ Time Frame: 30 days, 6, 12, 24, 60 months ] [ Designated as safety issue: Yes ]
consisting of thrombotic occlusion of the treated segment, target lesion revascularization, myocardial infarction, or death

Estimated Enrollment:	90
Study Start Date:	March 2010
Estimated Study Completion Date:	March 2015
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sequent®Please: Active Comparator	Device: SeQuent®Please (Paclitaxel coated balloon) PCI of de-novo lesions
Taxus™Liberté™: Active Comparator	Device: Taxus™Liberté™ (Paclitaxel eluting stent) PCI of de-novo lesions

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084408

Contacts

Contact: Bruno Scheller, Prof. Dr.med

+49(0)6841 162 3350

bruno.scheller@uks.eu

Locations

Germany, Brandenburg
Klinik für Kardiologie, Angiologie und Konservative Intensivtherapie Klinikum Ernst von Bergmann
Postdam, Brandenburg, Germany, 14467
Germany
Medizinisches Versorgungszentrum
Hamburg, Germany, 22527

Sponsors and Collaborators

University Hospital, Saarland

B. Braun Melsungen AG

Investigators

Principal Investigator:

Bruno Scheller, Prof. Dr. med

Uniklinikum des Saarlandes

More Information

No publications provided

Responsible Party:	Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, 66421 Homburg/Saar ( Bruno Scheller / Prof. Dr. med )
ClinicalTrials.gov Identifier:	NCT01084408 History of Changes
Other Study ID Numbers:	Pac 14
Study First Received:	March 9, 2010
Last Updated:	March 9, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital, Saarland:

de-novo
coronary stenoses
PEPCAD
DEBonly
Paclitaxel

Additional relevant MeSH terms:

Constriction, Pathologic
Pathological Conditions, Anatomical
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 01, 2010