European Multicenter, Randomized, Comparative Efficacy/Safety Study of the Mar-Tyn TiN-Coated Stent

NCT00637104 | Unknown Phase 2 DMC

• 1 other identifier: IBS/03-2007
• Study Type: interventional
• Target: 160
• Locations: 4 countries
• Sites: 7

Brief Summary

The main objective of this study is to assess the safety and effectiveness of the TiN-coated MAR-Tyn stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to an uncoated control cobalt-chromium balloon-expandable stent (Vision, Abbott Vascular). Both stents are mounted on a Rapid Exchange Stent Delivery System.

Conditions

Coronary Artery Disease; Angioplasty, Transluminal, Percutaneous Coronary; Stents

Keywords

percutaneous transluminal coronary angioplasty; stents; restenosis; biocompatible materials; ceramics

Outcome Measures

Primary Outcomes (1)

• in-stent minimum lumen diameter (MLD)

  6 months

Secondary Outcomes (4)

• Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, thrombosis, or repeat target lesion revascularization

  30 days, 6 months, 12 months

• Angiographic binary restenosis (>50% diameter stenosis) 6 months post-procedure. In-lesion minimum lumen diameter (MLD) at 6 months post-procedure.

  6 months

• Target lesion revascularization (TLR) at 6 months post-procedure. Target vessel revascularization (TVR) at 6 months post-procedure.

  6 months

• • Device success defined as achievement of a final residual diameter stenosis of <30% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used.

  6 months

Study Arms (2)

A - Mar-tyn

EXPERIMENTAL

It includes the implant of the Mar-tyn TiN coated stent

Device: Mar-Tyn TiN coated Co-Cr Numen stent implant

B - Vision

ACTIVE COMPARATOR

Includes all the patients treated with the Vision stent

Device: Vision Co-Cr stent implant

Interventions

Mar-Tyn TiN coated Co-Cr Numen stent implant DEVICE

Implant of the Mar-tyn TiN coated stent

Also known as: Mar-Tyn, martin, TiN coated stent

A - Mar-tyn

Vision Co-Cr stent implant DEVICE

Implant of the Vision stent

Also known as: cobalt-chromium stent

B - Vision

Eligibility Criteria

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

You may qualify if:

• Patients must meet ALL of the following criteria:
• The patient must be \> 18 years of age;
• Female of childbearing potential must have a negative pregnancy test within 7 days of enrollment and utilize reliable birth control for eight months after enrollment
• Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II) OR patients with documented silent ischemia;
• Single treatment of de novo lesion in a major coronary artery in patients with single or multi-vessel disease; patients with multiple lesions can be included only if the other lesions do not require treatment;
• Target vessel diameter at the lesion site is \>2.50mm and \<3.5mm in diameter (visual estimate);
• Target lesion is \>10mm and \<22mm in length (visual estimate);
• Target lesion stenosis is \>50% and \<100% (visual estimate);
• At least TIMI II coronary flow;
• Acceptable candidate for coronary artery bypass surgery (CABG);
• Patient is willing to comply with the specified follow-up evaluation;
• Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee.
• Patient can be pre-treated with aspirin and clopidogrel or, alternatively, aspirin alone plus a loading dose of 300 mg of clopidogrel before procedure completion in case of urgent PCI

You may not qualify if:

• Patients will be excluded if ANY of the following conditions apply:
• Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK \>2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment;
• Has unstable angina classified as Braunwald III B or C and A I-II-III, or is having a peri infarction;
• Unprotected left main coronary disease with \>50% stenosis;
• Significant (\>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede runoff;
• Have an ostial target lesion;
• Have a target lesion in a venous graft;
• Angiographic evidence of thrombus within target lesion;
• Calcified lesion which cannot be successfully predilated;
• Documented left ventricular ejection fraction \<=25%;
• Totally occluded vessel (TIMI 0 level);
• Impaired renal function (creatinine \> 3.0 mg/dl) at the time of treatment;
• Pretreatment with devices other than balloon angioplasty;
• Target lesion has excessive tortuousity or angulation (\> 45°) which makes it unsuitable for stent delivery and deployment;
• Target lesion involves bifurcation including a diseased side branch \>=2 mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require side branch stenting;

Sponsors & Collaborators

• International Biomedical Systems S.p.A.: lead

Study Sites (7)

Department of Internal Medicine III (Cardiology), University of Freiburg im Breisgau

Freiburg im Breisgau, 79106, Germany

RECRUITING

Policlinico Universitario di Bari-Emodinamica Interventista

Bari, BA, Italy

RECRUITING

Ospedale San Raffaele- Emodinamica e Cardiologia

Milan, MI, Italy

RECRUITING

Ospedale di Ravenna, U.O. Cardiologia

Ravenna, Ra, Italy

RECRUITING

Campus Biomedico, Cardiologia

Roma, Roma, Italy

RECRUITING

CARIM, Department of Cardiology

Maastricht, Netherlands

RECRUITING

Cardiocentro Ticino, Cardiologia

Lugano, Switzerland

RECRUITING

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

• Marco Balducelli, MD,FESC,FACC

  Ospedale "S.Maria delle Croci" - Ravenna, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Marras, Dr. MEng. PhD.

CONTACT

+39 3346738578; luigi.marras@ibsmed.it

Nader Shehata, Dr. Eng.

CONTACT

+39 040 3755 639; Nader.shehta@ibsmed.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 10, 2008
• First Posted: March 17, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: February 9, 2010

Record last verified: 2010-02

Locations

NL (1); DE (1); IT (4); CH (1)