SPIRIT FIRST Clinical Trial of the Abbott Vascular XIENCE V® Everolimus Eluting Coronary Stent System

NCT00180453 | Completed Phase 3 DMC

• 1 other identifier: 02-350
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 7

Brief Summary

Prospective, randomized, controlled, single-blinded, parallel two-arm, multicenter trial. Test arm: XIENCE V® Everolimus Eluting Coronary Stent System(stent length: 18mm, diameter: 3.0mm) Control arm: Metallic stent (MULTI-LINK VISION® metallic stent(stent length: 18mm, diameter: 3.0mm) Follow-up angiographic imaging and intra vascular ultra sound (IVUS) at 180 days and 1 year

Conditions

Coronary Artery Disease; Everolimus; Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis

Keywords

Cardiovascular disease; Ischemia

Outcome Measures

Primary Outcomes (1)

• In-stent late loss

  at 180 days post procedure

Secondary Outcomes (9)

• In-stent late loss

  at 1 year post procedure

• In-segment Late Loss

  at 180 days and 1 year

• In-stent and in-segment %Volume Obstruction

  at 180 days and 1 year

• In-stent and in-segment %Diameter Stenosis

  at 180 days and 1 year

• In-stent and in-segment Angiographic Binary Restenosis rate

  at 180 days and 1 year

Study Arms (2)

1

EXPERIMENTAL

Abbott Vascular XIENCE V® Everolimus Eluting Coronary Stent System

Device: Coronary artery drug eluting stent placement

2

ACTIVE COMPARATOR

Abbott Vascular MULTI-LINK VISION® BMS

Device: Coronary artery stent placement

Interventions

Coronary artery drug eluting stent placement DEVICE

Coronary artery drug eluting stent placement

1

Coronary artery stent placement DEVICE

Coronary artery stent placement

Also known as: Abbott Vascular MULTI-LINK VISION® coronary stent system

2

Eligibility Criteria

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

You may qualify if:

• Patient must be at least 18 years of age.
• Patient is able to verbally acknowledge an understanding of the associated risks, benefits and treatment alternatives of receiving the XIENCE™ V Everolimus Eluting Coronary Stent System and his or her legally authorized representative provides written informed consent prior to the stent procedure, as approved by the appropriate Ethics Committee.
• Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study).
• Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
• Patient must agree to undergo all protocol-required follow-up examinations including angiographic and IVUS follow-up at two time points (180 days and 1 year ).
• Female patients of childbearing potential must have had a negative pregnancy test within 7 days before treatment, and must not be nursing at the time of treatment.
• Female patients of childbearing potential must also agree at time of consent to use birth control up to and including the second angiographic follow-up at 1 year.
• Planned single, de novo, type A - B1, native coronary artery lesion treatment.
• Target lesion must be located in a native vessel with a diameter of 3.0 mm assessed by QCA on-line.
• Target lesion length ≤ 12 mm, assessed by QCA on-line.
• The target lesion must be in a major artery or branch with a stenosis of ≥ 50% and \< 100% assessed by QCA on-line and with a TIMI flow of ≥ 1.

You may not qualify if:

• Patient has had a known acute myocardial infarction (greater than two times the upper limit of normal CK with presence of CK-MB) within 3 days preceding the index procedure and CK has not returned to normal limits at the time of the procedure.
• Patient has current or a history of unstable arrhythmias, regardless of whether cardiac rhythm management devices are used (e.g., pacemaker, Automatic Implantable Cardioverter Defibrillator).
• Patient has a known left ventricular ejection fraction ≥ 30%.
• Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant.
• Patient is receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.
• Patient is receiving immunosuppression therapy or has known immunosuppressive disease.
• Patient is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).
• Patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, cobalt, chromium, nickel, tungsten, everolimus, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
• Patient has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3, a WBC of \<3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).
• Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, patient on dialysis).
• Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• Patient has had a cerebrovascular accident (CVA) or stroke or transient ischemic neurological attack (TIA) within the past six months.
• Patient has had a significant GI or urinary bleed within the past six months.
• Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion or extreme anticoagulation.
• Patient has other medical illness (e.g., cancer or congestive heart failure) or recent history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (7)

Skejby Sygehus

Aarhus, Denmark

Location

Herzzentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Kerckhoff-Klinik

Bad Nauheim, 61231, Germany

Location

Herzzentrum Bad Oeynhausen

Bad Oeynhausen, 32545, Germany

Location

Herzzentrum Siegburg GmbH

Siegburg, Germany

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Related Publications (6)

• Tsuchida K, Garcia-Garcia HM, Ong AT, Valgimigli M, Aoki J, Rademaker TA, Morel MA, van Es GA, Bruining N, Serruys PW. Revisiting late loss and neointimal volumetric measurements in a drug-eluting stent trial: analysis from the SPIRIT FIRST trial. Catheter Cardiovasc Interv. 2006 Feb;67(2):188-97. doi: 10.1002/ccd.20581.

  PMID: 16400664 BACKGROUND

• Popma JJ, Tulli M. Spirit First - Another hurdle is cleared. EuroIntervention. 2005 Nov;1(3):260-3. No abstract available.

  PMID: 19758913 RESULT

• Serruys PW, Ong AT, Piek JJ, Neumann FJ, van der Giessen WJ, Wiemer M, Zeiher A, Grube E, Haase J, Thuesen L, Hamm C, Otto-Terlouw PC. A randomized comparison of a durable polymer Everolimus-eluting stent with a bare metal coronary stent: The SPIRIT first trial. EuroIntervention. 2005 May;1(1):58-65.

  PMID: 19758878 RESULT

• Tsuchida K, Piek JJ, Neumann FJ, van der Giessen WJ, Wiemer M, Zeiher AM, Grube E, Haase J, Thuesen L, Hamm CW, Veldhof S, Dorange C, Serruys PW. One-year results of a durable polymer everolimus-eluting stent in de novo coronary narrowings (The SPIRIT FIRST Trial). EuroIntervention. 2005 Nov;1(3):266-72.

  PMID: 19758915 RESULT

• SPRITI FIRST: 2-Jahres-ergebnisse. A durable polymer everolimus-eluting stent in de novo coronary narrowings. Richartz B.; Silber S. Herz ( Germany ) June 1, 2006 , 31/4 (359). ISSN: 0340-9937. Language: German

  RESULT

• Muramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, Diletti R, Garcia-Garcia HM, Dorange CC, Veldhof S, Cheong WF, Ozaki Y, Whitbourn R, Bartorelli A, Stone GW, Abizaid A, Serruys PW; ABSORB Cohort B Investigators; ABSORB EXTEND Investigators; SPIRIT FIRST Investigators; SPIRIT II Investigators; SPIRIT III Investigators; SPIRIT IV Investigators. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014 May;7(5):482-93. doi: 10.1016/j.jcin.2014.01.155. Epub 2014 Apr 16.

  PMID: 24746650 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Vascular Diseases; Myocardial Ischemia; Coronary Stenosis; Cardiovascular Diseases; Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Serruys, MD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: December 1, 2003
• Primary Completion: April 1, 2005
• Study Completion: June 1, 2009
• Last Updated: January 6, 2010

Record last verified: 2009-06

Locations

NL (2); DE (4); DK (1)