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

Coronary Artery Disease Clinical Trial

Official title:

SPIRIT First: A Clinical Evaluation of an Investigational Device. The Abbott XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180453
• Other study ID #: 02-350
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: January 5, 2010
• Start date: December 2003
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial 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

Description:

The SPIRIT FIRST clinical trial will enroll approximately 60 patients and will assess the feasibility and performance of the XIENCE V® Everolimus Eluting Coronary Stent System in the treatment of patients with de novo native coronary artery lesions. In this trial, the XIENCE V® Everolimus Eluting Coronary Stent System will be compared to the MULTI-LINK VISION® metallic stent which is CE marked and FDA approved and is available for commercial use in Europe and in the United States. The SPIRIT FIRST Clinical trial will enroll approximately 60 patients (30 patients in the test arm and 30 patients in the control arm) with de novo native coronary artery lesions in 4 clinical sites in The Netherlands and Germany

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2009
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Patient must be at least 18 years of age.

2. 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.

3. Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study).

4. Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.

5. 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 ).

6. 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.

7. 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.

Inclusion Criteria: Angiographic

1. Planned single, de novo, type A - B1, native coronary artery lesion treatment.

2. Target lesion must be located in a native vessel with a diameter of 3.0 mm assessed by QCA on-line.

3. Target lesion length = 12 mm, assessed by QCA on-line.

4. 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.

Exclusion Criteria

1. 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.

2. 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).

3. Patient has a known left ventricular ejection fraction = 30%.

4. Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant.

5. Patient is receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.

6. Patient is receiving immunosuppression therapy or has known immunosuppressive disease.

7. Patient is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).

8. 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.

9. 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).

10. Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, patient on dialysis).

11. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.

12. Patient has had a cerebrovascular accident (CVA) or stroke or transient ischemic neurological attack (TIA) within the past six months.

13. Patient has had a significant GI or urinary bleed within the past six months.

14. Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion or extreme anticoagulation.

15. 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).

16. Patient is already participating in another investigational use device or drug study or has completed the follow-up phase of another trial within the last 30 days.

17. Patient has received a drug eluting stent within the last 1 year.

Exclusion Criteria: Angiographic

1. The target lesion meets any of the following criteria:

1. Aorto-ostial location

2. Unprotected left main location

3. Located within 2 mm of the origin of the LAD or LCX

4. Located within or distal to an arterial or saphenous vein graft

5. Located within 2 mm of a bifurcation

6. Located distal to a previously implanted stent (same major epicardial vessel)

7. Located in a major epicardial vessel that has been previously treated with brachytherapy

8. Located in a major epicardial vessel that has been previously treated with any type of PCI (e.g., POBA, stent, cutting balloon, atherectomy), except if previous treatment occurred in a side branch distal to target lesion at least 180 days preceding the index procedure

9. Involves jailing of side branches > 2.0 mm in diameter

10. Total occlusion (TIMI flow 0)

11. Excessive tortuosity proximal to or within the lesion

12. Extreme angulation (= 90%) proximal to or within the lesion

13. Moderate to heavy calcification

14. Restenotic from previous intervention

2. The target vessel contains thrombus.

3. Another significant lesion (= 40 %DS) is located in the same major epicardial vessel as the target lesion.

4. Patient has a high probability that a procedure other than pre-dilatation and stenting will be required for treatment of the target vessel (e.g. atherectomy, cutting balloon).

5. Patient has additional lesion(s) for which an intervention within 180 days (prior to or after) of the index procedure would be required or has been performed.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Disease
• Coronary Stenosis
• Everolimus
• Myocardial Ischemia
• Vascular Disease
• Vascular Diseases

Intervention

Device:
• Coronary artery drug eluting stent placement
Coronary artery drug eluting stent placement
• Coronary artery stent placement
Coronary artery stent placement

Locations

Country	Name	City	State
Denmark	Skejby Sygehus	Aarhus
Germany	Herzzentrum Bad Krozingen	Bad Krozingen
Germany	Kerckhoff-Klinik	Bad Nauheim
Germany	Herzzentrum Bad Oeynhausen	Bad Oeynhausen
Germany	Herzzentrum Siegburg GmbH	Siegburg
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Countries where clinical trial is conducted

Denmark,  Germany,  Netherlands, 

References & Publications (5)

Popma JJ, Tulli M. Spirit First - Another hurdle is cleared. EuroIntervention. 2005 Nov;1(3):260-3. — View Citation

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 — View Citation

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

Tsuchida K, García-García 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. — View Citation

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 FIR — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent late loss		at 180 days post procedure	Yes
Secondary	In-stent late loss		at 1 year post procedure	Yes
Secondary	In-segment Late Loss		at 180 days and 1 year	Yes
Secondary	In-stent and in-segment %Volume Obstruction		at 180 days and 1 year	Yes
Secondary	In-stent and in-segment %Diameter Stenosis		at 180 days and 1 year	Yes
Secondary	In-stent and in-segment Angiographic Binary Restenosis rate		at 180 days and 1 year	Yes
Secondary	Persisting incomplete apposition, late incomplete apposition, aneurysm, thrombus, persisting dissection		at 180 days and 1 year	Yes
Secondary	Major Adverse Cardiac Events		at 30, 180, 270 days, and 1, 2, 3, 4, 5 years	Yes
Secondary	Target Vessel Failure		at 30, 180, 270 days, and 1, 2, 3, 4, 5 years	Yes
Secondary	Acute success (device, procedure and clinical)		Acute	Yes

External Links

•   Clinical impact of in-stent late loss after drug-eluting coronary stent implantation
•   Comparison of in vivo acute stent recoil between the bioabsorbable everolimus-eluting coronary stent and the everolimus-eluting cobalt chromium coronary stent: Insights from the ABSORB and SPIRIT trials