A Study of the Presillion Stent in de Novo Coronary Lesions

NCT00722579 | Completed Phase 3 DMC

• 1 other identifier: EC08-01
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The PRESILLION Study is a non-randomized, multi-center, single-arm study evaluating the safety of an approved Cobalt Chromium bare metal stent system for the treatment of ischemic heart disease attributable to a stenotic de novo lesion in a native coronary artery. The study population will include 100 patients with up to two de novo native coronary artery lesions with a maximum lesion length of 30mm in a maximum of two major coronary arteries with reference vessel diameter \>= 2.5mm and \<= 4.0mm by visual estimation. Patients will be followed for 1 month and 6 month post-procedure for assessment of MACE and all other adverse events.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Composite of MACE which includes cardiac death, myocardial infarction (Q-wave and non Q-wave) and clinically driven target lesion revascularization (TLR).

  1-month and 6-months post-procedure

Secondary Outcomes (10)

• Clinically driven Target Lesion Revascularization (TLR) defined as repeat PCI or CABG to the target lesion.

  1-month and 6-months post-procedure

• Clinically driven Target Vessel Revascularization (TVR) defined as repeat PCI or CABG to the target vessel.

  1-month and 6-months post-procedure

• Target Vessel Failure (TVF) defined as target vessel revascularization, recurrent myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel.

  1-month and 6-months post-procedure

• Myocardial Infarction (MI).

  1-month and 6-months post-procedure

• Major bleeding.

  1-month and 6-months post-procedure

Study Arms (1)

A

EXPERIMENTAL

The PRESILLION TM Coronary Stent is an L-605 cobalt chromium (CoCr) stent.

Device: PRESILLION cobalt chromium stent

Interventions

PRESILLION cobalt chromium stent DEVICE

PTCA with bare-metal stent

Also known as: bare-metal stent

A

Eligibility Criteria

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

You may qualify if:

• The patient must be \>= 18 years of age.
• Patient is eligible for percutaneous coronary intervention (PCI).
• Acceptable candidate for coronary artery bypass surgery (CABG).
• Female patients of childbearing potential must have a negative pregnancy test within 7 days prior to enrolment and utilize reliable birth control for trial duration.
• 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-III) or patients with documented silent ischemia.
• Treatment of up to two de novo native coronary artery lesions in a maximum of two major coronary arteries.
• Target reference vessel diameter of both lesions must be \>= 2.5mm and \<= 4.0mm in diameter (visual estimate).
• Target lesion length must be \<= 30mm and be covered by one study stent.
• Target lesion stenosis for both lesions is \> 50% and \< 100% (visual estimate).
• At least TIMI I coronary flow.
• 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.

You may not qualify if:

• Recent myocardial infarction (either STEMI or non STEMI \< 48 hours prior to planned index procedure).
• The patient has unstable angina classified as Braunwald A I-II-III.
• The patient has unprotected left main coronary artery disease (stenosis \>50%).
• A significant (\> 50%) stenosis proximal or distal to the target lesion.
• Angiographic evidence of thrombus within the target lesion.
• Heavily calcified lesion and/or calcified lesion, which cannot be successfully predilated and/or an excessively tortuous vessel which makes it unsuitable for stent delivery and deployment.
• Left ventricular ejection fraction \<= 25%.
• Totally occluded lesion (TIMI 0 level).
• The patient has impaired renal function (creatinine 3.0mg/dL) at the time of treatment.
• The patient had a Cerebrovascular Accident (CVA) within the past 6 months.
• Prior stent within 10mm of target lesion.
• The target lesion is ostial in location (within 3.0mm of vessel origin).
• The target lesion involves a bifurcation with a diseased (\>50% stenotic) branch vessel \>= 2.0mm in diameter (or side branch requiring intervention of protection).
• The target lesion is located in a bypass graft. Note: stenting of lesions in bypassed native coronary arteries is allowed.
• Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix ®) and ticlopidine (Ticlid ®), heparin, cobalt chromium, contrast agent (that cannot be managed medically).

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

CHU de Liège

Liège, B-4000, Belgium

Location

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

• V. Legrand, MD, Phd

  Centre Hospitalier Universitaire de Liege

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 24, 2008
• First Posted: July 25, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: March 1, 2010
• Last Updated: June 14, 2010

Record last verified: 2010-06

Locations

BE (1)