Clinical trial NCT00754728: "JACTAX" Trial Drug Eluting Stent Trial
Official title: "JACTAX" Trial Drug Eluting Stent Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Labcoat, Ltd.
First posted: 2008-09-18
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 criteria: General Inclusion Criteria:

1. Patient is ≥ 18 years of age
2. Patient is eligible for percutaneous coronary intervention (PCI)
3. Patient demonstrates LVEF of ≥ 25%
4. Patient or legal guardian understands and agrees to comply with all specified study requirements and provides written informed consent to this effect

Angiographic Inclusion Criteria:

1. Target lesion is de novo native coronary artery lesion (i.e., a coronary lesion not previously treated)
2. 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)
3. Reference vessel diameter is between 2.75mm and 3.5 mm
4. Study lesion diameter stenosis is ≥70%
5. Study lesion has been successfully pre-dilated
6. Patients enrolled for treatment may demonstrate multiple lesions in target vessel. However lesions must be covered completely by one study stent
7. 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
8. 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.

General Exclusion Criteria:

1. The patient has a life expectancy of less than 24 months due to another medical condition
2. Patient has a history of hypersensitivity to paclitaxel or structurally related compounds
3. 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
4. Patient demonstrates evidence of acute or chronic renal dysfunction (serum creatinine \>2.0 mg/dl or 177umol/l)
5. Planned cardiac surgery procedure \<= 9 months post index procedure
6. 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
7. Patient exhibits acute ST segment elevation MI (STEMI) within 72 hours prior to the index procedure
8. CVA including stroke or TIA within 3 months
9. Patient demonstrates evidence of leukopenia
10. Patient demonstrates evidence of thrombocytopenia or thrombocytosis
11. Patient is contraindicated to ASA, clopidogrel or ticlopidine
12. Patient is currently on warfarin, or possibility of treatment with warfarin during the following 6 months post index procedure
13. Patient has been treated with paclitaxel or other chemotherapeutic agents within 12 months prior to planned index procedure
14. Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9 months after the index procedure
15. Patient has received a drug eluting stent within 12 months prior to planned index procedure
16. Previous or planned treatment with intravascular brachytherapy in target vessel
17. Known allergy to stainless steel
18. Male or female with known intention to procreate within 3 months after the index procedure
19. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating or intends to become pregnant during the 12 months post index procedure

Angiographic Exclusion Criteria

1. Evidence of probable or definite thrombus of the study vessel, based on angiography or IVUS
2. Study lesion is totally occluded (TIMI flow \<= 1) either at baseline or before pre-dilatation
3. Study lesion, or the study vessel proximal to the study lesion is moderately or severely calcified by visual estimate
4. Study lesion is ostial in location (within 3.0 mm of vessel origin)
5. Study lesion involving arterial segments with highly tortuous anatomy or where lesion is located within or distal to a \>60 degree bend in the vessel
6. Study lesion involves a bifurcation with a diseased (\>50% stenotic) branch vessel \>2.0 mm in diameter
7. Left main coronary artery disease (stenosis \>50%) branch vessel \> 2.0 mm in diameter
8. Target lesion length \>20 mm based on visual estimate by operator
9. Target vessel diameter \>3.5 mm based on visual estimate by operator
10. Target vessel diameter \<2.75 mm based on visual estimate by operator
11. Pre-treatment of the target lesion (excluding predilation) with another interventional device

Primary outcomes:
measure: MACE at 9 months
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
city: Hamburg
country: Germany
facility: Hamburg University CardioVascular Center
city: Siegburg
country: Germany
facility: HELIOS Klinikum
city: Trier
country: Germany
facility: Krankehaus der Barmherzigen Bruder
city: Southampton
country: United Kingdom
facility: Southampton NHS
Study officials:
affiliation: Elizabeth Hospital, Essen Germany
name: Eberhard Grube
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.