"JACTAX" Trial Drug Eluting Stent Trial

NCT00754728 | Completed DMC

• 1 other identifier: LBCT-H01-07
• Study Type: interventional
• Target: 103
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• MACE at 9 months

  9 months

Study Arms (1)

I

EXPERIMENTAL

Device: JACTAX DES

Interventions

JACTAX DES DEVICE

Drug Eluting Stent

Also known as: JACTAX

I

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 is eligible for percutaneous coronary intervention (PCI)
• Patient demonstrates 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)
• Target lesion can be treated with one stent, with overlap onto the healthy tissue, as specified in visual estimate guidelines.Max lesion length is 20 mm(i.e. approximately 4mm on each side, based on visual estimate and available stent lengths)
• Reference vessel diameter is between 2.75mm and 3.5 mm
• Study lesion diameter stenosis is ≥70%
• 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 treatment. 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 either a TAXUS paclitaxel eluting stent or a bare metal 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 \<80 mmHg and PCWP\> 20mm Hg or cardiac index \<1.8 liters/m or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure \>80 mmHg) 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 177umol/l)
• Planned cardiac surgery procedure \<= 9 months post index procedure
• Patient demonstrates evidence of a myocardial infarction (elevated CK, CKMB or Troponin) within 72 hours prior to index procedure and/or CK\> 2X local lab's ULN, unless CK-MB is \<2X ULN
• Patient exhibits acute ST segment elevation MI (STEMI) within 72 hours prior to the index procedure
• CVA including stroke or TIA within 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 on 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

Hamburg University CardioVascular Center

Hamburg, Germany

Location

HELIOS Klinikum

Siegburg, Germany

Location

Krankehaus der Barmherzigen Bruder

Trier, Germany

Location

Southampton NHS

Southampton, United Kingdom

Location

Related Publications (1)

• Grube E, Schofer J, Hauptmann KE, Nickenig G, Curzen N, Allocco DJ, Dawkins KD. A novel paclitaxel-eluting stent with an ultrathin abluminal biodegradable polymer 9-month outcomes with the JACTAX HD stent. JACC Cardiovasc Interv. 2010 Apr;3(4):431-8. doi: 10.1016/j.jcin.2009.12.015.

  PMID: 20398872 DERIVED

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2008
• First Posted: September 18, 2008
• Study Start: July 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: January 1, 2010
• Last Updated: March 1, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); GB (1)