"JACTAX" Trial Drug Eluting Stent Trial - Full Text View

Sponsored by:	Labcoat, Ltd.
Information provided by:	Labcoat, Ltd.
ClinicalTrials.gov Identifier:	NCT00754728

Purpose

Prospective, multi-center, non-randomized registry. 100 patients will be enrolled at up to 10 clinical sites in Europe. The results of this study will be compared to the TAXUS™ ATLAS clinical trial to evaluate the safety of the product.

Condition	Intervention
Coronary Artery Disease	Device: JACTAX DES

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	"JACTAX" Trial Drug Eluting Stent Trial

Further study details as provided by Labcoat, Ltd.:

Primary Outcome Measures:

MACE at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Enrollment:	103
Study Start Date:	July 2007
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental	Device: JACTAX DES Drug Eluting Stent

Detailed Description:

The JACTAX Drug Eluting Stent has been designed to minimize the amount of polymer in contact with the vessel surface, thus potentially reducing the incidence of untoward side effects. The Juxtaposed Ablumenal Coating Process is capable of exclusive coating on the ablumenal side of pre-mounted bare metal stents. Juxtaposed Ablumenal Coating is a proprietary formulation containing a bioerodable polymer. The combination of the Juxtaposed Ablumenal Coating Process and Juxtaposed Ablumenal Coating create a unique microstructure surface, and reduces the amount of required polymer.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is ≥ 18 years of age
Patient is eligible for percutaneous coronary intervention (PCI)

Exclusion Criteria:

The patient has a life expectancy of less than 24 months due to another medical condition
Patient has a history of hypersensitivity to paclitaxel or structurally related compounds

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754728

Sponsors and Collaborators

Labcoat, Ltd.

Investigators

Principal Investigator:

Eberhard Grube

HELIOS Klinikum Siegburg

More Information

Responsible Party:	Labcoat, Ltd. ( Philip Watson )
Study ID Numbers:	LBCT-H01-07
Study First Received:	September 16, 2008
Last Updated:	September 16, 2008
ClinicalTrials.gov Identifier:	NCT00754728
Health Authority:	Germany: Ethics Commission

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009