Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets

Coronary Artery Disease Clinical Trial

— SPECIALIST  

Official title:

Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01670318
• Other study ID #: SPECIALIST Registry
• Status: Recruiting
• Phase: N/A
• First received: August 16, 2012
• Last updated: August 21, 2012
• Start date: August 2012
• Est. completion date: December 2015

Study information

• Verified date: August 2012
• Source: The PCI Guideline Research Society
• Contact: Kenya Nasu, MD, FACC
• Phone: +81532373377
• Email: yuyatomoya[@]gmail.com
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Randomized trials have demonstrated an excellent safety and efficacy profile for the chromium everolimus-eluting stent. The platinum chromium everolimus-eluting sten (PtCr-EES) uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. However, the efficacy of the PtCr-EES for complex coronary artery diseases subsets such as chronic total occlusion, bifurcation lesion, left main trunk disease, and small vessel diseases is still unknown.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

1. A patient with ischemic heart disease including stable angina pectoris and acute coronary syndrome

2. Male or non-pregnant female

3. Key lesion inclusion criteria as follows

1. Multi-vessel diseases

2. Long lesion (lesion length >30mm by visual estimation)

3. Small vessel disease (reference diameter <2.5mm by visual estimation)

4. Bifurcation lesion

5. Ostial lesion

6. Calcified lesion

7. Protected or non-protected left main trunk disease

8. Chronic total occlusion

9. In stent restenosis of bare metal stent or everolimus-eluting stent

Exclusion Criteria:

1. Hypersensitivity to cobalt chromium, everolimus, heparin, aspirin, ticlopidine, clopidogrel or X-ray contrast media.

2. Serum creatinine level >3.0 mg/dL

3. Other concomitant disease or medical condition that could impact patient/procedural outcomes, such as history of bleeding diathesis or cancer within 5 years.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)

Locations

Country	Name	City	State
Japan	Ayase Heart Hospital	Adachi-ku	Tokyo
Japan	Kansai Rosai Hospital	Amagasaki	Hyogo
Japan	Tokyo Rinkai Hospital	Edogawa-ku	Tokyo
Japan	Megumino Hospital	Eniwa	Hokkaido
Japan	Saiseikai Fukuoka General Hospital	Fukuoka
Japan	Seirei Mikatahara General Hospital	Hamamatsu	Shizuoka
Japan	Itabashi Chuo Medical Center	Itabashi-ku	Tokyo
Japan	Rinku General Medical Center	Izumisano	Osaka
Japan	Kakogawa East City Hospital	Kakogawa	Hyogo
Japan	Kasukabe Chuo General Hospital	Kasukabe	Saitama
Japan	SHUWA General Hospital	Kasukabe	Saitama
Japan	Katsushika Medical Center	Katsushika-ku	Tokyo
Japan	Tokyo-Kita Social Insurance Hospital	Kita-ku	Tokyo
Japan	Kokura Memorial Hospital	Kitakyushu	Fukuoka
Japan	Kobe University Hospital	Kobe	Hyogo
Japan	Hoshi General Hospital	Koriyama	Fukushima
Japan	Southern Tohoku Research Institute for Neuroscience	Koriyama	Fukushima
Japan	Saiseikai Kumamoto Hospital	Kumamoto
Japan	Gunma Prefectural Cardiovascular Center	Maebashi	Gunma
Japan	Gunma University Hospital	Maebashi	Gunma
Japan	Matsumoto Kyoritsu Hospital	Matsumoto	Nagano
Japan	The Cardiovascular Institute	Minato-ku	Tokyo
Japan	JA Hokkaido Engaru Kosei General Hospital	Monbetsu	Hokkaido
Japan	Aichi Medical University Hospital	Nagakute	Aichi
Japan	Tokyo Metropolitan Police Hospital	Nakano-ku	Tokyo
Japan	Nayoro City General Hospital	Nayoro	Hokkaido
Japan	Ota Memorial Hospital	Ota	Gunma
Japan	Sapporo Cardio Vascular Clinic	Sapporo	Hokkaido
Japan	Tokyo Metropolitan Hiroo Hospital	Shibuya-ku	Tokyo
Japan	NTT Medical Center Tokyo	Shinagawa-ku	Tokyo
Japan	Hokusetsu General Hospital	Takatsuki	Osaka
Japan	TODA CHUO General Hospital	Toda	Saitama
Japan	Toyohashi Heart Center	Toyohashi	Aichi
Japan	Tsukuba Medical Center Hospital	Tsukuba	Ibaragi
Japan	Daini Okamoto General Hospital	Uji	Kyoto
Japan	Juntendo University Urayasu Hospital	Urayasu	Chiba
Japan	Yokohama City Minato Red Cross Hospital	Yokohama	Kanagawa
Japan	Yokohama Rosai Hospital	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
The PCI Guideline Research Society

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization		12 month	No
Secondary	Successful stent delivery with final percent diameter stenosis less than 50% at minimum lumen diameter site		In hospital	Yes
Secondary	Target lesion revascularization		12 month	No
Secondary	Target vessel revascularization		12 month	No
Secondary	Myocardial infarction		24 month	No
Secondary	Cardiac death		24 month	No
Secondary	Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization		24 month	No
Secondary	Stent thrombosis (acute, sub-acute, late,and very late) defined by Academic Research Consortium (ARC)		24 month	No