JACTAX LD Drug Eluting Stent Trial

NCT00754975 | Completed DMC

• 1 other identifier: LBCT-H02-07
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 5

Brief Summary

Prospective, multi-center, randomized trial. A maximum of 130 patients will be enrolled, in a 2:1 ratio to receive either the JACTAX LD stent or the TAXUS™ Libertè™ stent to evaluate the efficacy of the product.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• MACE rate at 9 months

  9 months

Study Arms (2)

I

EXPERIMENTAL

JACTAX LD DES

Device: JACTAX LD DES

II

ACTIVE COMPARATOR

TAXUS™ Libertè™ DES

Device: TAXUS™ Libertè™ DES

Interventions

JACTAX LD DES DEVICE

Drug Eluting Stent

I

TAXUS™ Libertè™ DES DEVICE

Drug Eluting Stent

II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is ≥ 18 years of age
• Patient with coronary artery disease, eligible for percutaneous coronary intervention (PCI)
• Patient demonstrates a LVEF of ≥ 25%
• Patient or legal guardian understands and agrees to comply with all specified study requirements and provides written informed consent to this effect.
• Target lesion is de novo native coronary artery lesion (i.e., a coronary lesion not previously treated)
• The target lesion can be treated with a maximum of one stent, with adequate coverage onto the healthy tissue, as specified in visual estimate guidelines. Maximum lesion length is 20mm.
• The reference vessel diameter is between 2.75mm and 3.5mm
• Study lesion diameter stenosis is ≥70% (visual estimate) and \<100% and a TIMI flow \>1.
• Study lesion has been successfully pre-dilated
• Patients enrolled for treatment may demonstrate multiple lesions in target vessel. However lesions must be covered completely by one study stent.
• Patient must have no more than two lesions requiring treatments. These lesions must be in different vessel distributions. For example, if the target lesion is in the LAD, then the non target lesion must be present in either the circumflex or RCA. The non-study lesion may not be in a branch vessel or distal to the target vessel location.
• The non target lesion must be successfully treated prior to the treatment of the target lesion. The non target lesion must be treated with a TAXUS paclitaxel eluting stent or a bare metal stainless steel stent.

You may not qualify if:

• 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
• Patient exhibits cardiogenic shock (systolic pressure \<80mmHg and PCWP \>20mmHg or cardiac index \<1.8 liters/minute/m or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure \>80mmHg) for any time within 24 hours prior to index procedure
• Patient demonstrates evidence of acute or chronic renal dysfunction (serum creatinine \>2.0 mg/dl or 177 umol/l)
• Planned cardiac surgery procedure \<= 9 months post index procedure
• Patient demonstrates evidence of myocardial infarction (elevated CK, CKMB or Troponin) within 72 hours prior to the index procedure and/or CK \>2X local lab's ULN, unless CK-MB is \< 2X ULN
• Patient exhibits acute ST segment elevation MI within 72 hours prior to the index procedure
• CVA including stroke or TIA within previous 3 months
• Patient demonstrates evidence of leukopenia
• Patient demonstrates evidence of thrombocytopenia or thrombocytosis
• Patient is contraindicated to ASA, clopidogrel or ticlopidine
• Patient is currently taking warfarin or possibility of treatment with warfarin during the following 6 months post index procedure
• Patient has been treated with paclitaxel or other chemotherapeutic agents within 12 months prior to planned index procedure
• Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9 months after the index procedure
• Patient has received a drug eluting stent within 12 months prior to planned index procedure

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• Labcoat, Ltd.: collaborator

Study Sites (5)

Universitatsklinikum Bonn

Bonn, Germany

Location

Cardiovascular Center Sankt Katharinen

Frankfurt, Germany

Location

Hamburg University CardioVascular Center

Hamburg, Germany

Location

HELIOS Klinikum

Siegburg, Germany

Location

Krankenhaus der Barmherzigen Bruder

Trier, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Eberhard Grube

  Elizabeth Hospital, Essen Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2008
• First Posted: September 18, 2008
• Study Start: January 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: July 1, 2010
• Last Updated: March 1, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)