Safety and Efficacy of RESTEN-MP When Used in Conjunction With a Bare Metal Stent in Coronary Arteries

NCT00248066 | Completed Phase 2

• 1 other identifier: AVI-4126-17
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

The process of re-narrowing of a coronary artery following a revascularization procedure such as angioplasty, begins at the time of the procedure. Restenosis has long been considered a major problem for effective long-term interventional success. This often results in repeated procedures to deal with recurrent stenosis (or restenosis) of the original targeted vessel. There is a substantial body of literature suggesting that local MYC protein production in the injured coronary artery is a major stimulus and potential cause of restenosis that appears after stent placement. This study is based upon the hypothesis that stopping MYC protein production in the vessel will help reduce restenosis (vessel re-narrowing). AVI BioPharma Inc., has utilized its proprietary antisense chemistry to design a drug that interferes with MYC production. This study will evaluate the safety and potential effectiveness of RESTEN-MP to reduce in-stent restenosis following balloon angioplasty and stent placement. The post-dose follow-up period is up to six-months. RESTEN-MP is administered at the time a stent is successfully placed in a coronary artery, and again 24 hours later, via slow-push intravenous administration.

Conditions

Coronary Artery Disease; Coronary Restenosis

Keywords

Coronary artery disease; Restenosis; Coronary stent restenosis

Outcome Measures

Primary Outcomes (2)

• Evaluate the potential efficacy of RESTEN-MP given intravenously upon confirmation of stent implantation and again at 24 hours post-stent implantation

• The therapeutic endpoint to assess potential efficacy is the prevention of coronary late lumen loss 6 months after the stent placement procedure, based on quantitative coronary angiography (QCA).

Secondary Outcomes (7)

• Major adverse cardiac events (MACE) defined as cardiac death, MI (Q wave and non-Q wave), emergent cardiac bypass surgery, and clinically-driven target lesion revascularization (TLR) at Days 14 and 30, and Month 6, 9 and 12 post-stent placement

• Target vessel failure (TVF) rate, defined as a composite of target vessel revascularization, recurrent MI (Q or Non Q-Wave), or cardiac death that could not be clearly attributed to a vessel other than the target vessel at Month 9 post-stent placement

• Angiographic binary restenosis (≥ 50% diameter stenosis) at Month 6 post-stent placement

• In-stent minimum lumen diameter (MLD) at Month 6 post-stent placement

• In-segment MLD at Month 6 post-stent placement

Interventions

RESTEN-MP DRUG

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years of age.
• An acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), coronary artery stenting, and emergent coronary artery bypass graft (CABG).
• Clinical evidence of ischemic heart disease or a positive functional study.
• The target lesion/vessel must meet the following criteria:
• The target lesion is a single de novo lesion that has not been previously treated with any interventional procedure. Only one lesion may be treated per subject.
• The target vessel must be a native coronary artery with a stenosis of ≥ 50% and \< 100%.
• The target lesion must be ≥ 10 mm and ≤ 30 mm in length.
• The target vessel reference diameter must be ≥ 2.5 mm and ≤ 4.0 mm.
• Female subjects of childbearing potential must have a documented negative serum pregnancy test within seven days before the procedure.
• The subject or the subject's legally authorized representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site.
• The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
• The subject is capable of providing informed consent and has provided written consent prior to study entry.

You may not qualify if:

• Documented left ventricular ejection fraction \< 30%.
• Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, stainless steel, or sensitivity to contrast media, which cannot be adequately pre-medicated.
• Evidence of an acute myocardial infarction within 72 hours of the intended treatment \[defined as: Q wave or non-Q wave infarction having creatine kinase (CK) enzymes ≥ 2 times the upper laboratory normal (with the presence of a CK-MB elevated above the Institution's upper limit of normal)\] or acute myocardial infarction in progress at time of treatment.
• Previous coronary interventional procedure of any kind within the 30 days prior to the stent-placement procedure.
• Planned interventional treatment of either the target or any non-target vessel within 30 days post-stent placement procedure is required.
• Target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, or rotational atherectomy).
• Previous stenting anywhere in the target vessel.
• Target vessel has evidence of thrombus or is excessively tortuous (2 bends \> 90° to reach the target lesion).
• Target lesion has any one of the following characteristics:
• Lesion location is aorto-ostial, an unprotected left main lesion, or within 5 mm of the origin of the left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX), or right coronary artery (RCA);
• Involves a side branch \> 2.0 mm in diameter;
• Is at or distal to a 45º bend in the vessel; or
• Is moderately to severely calcified.
• History of a stroke or transient ischemic attack within the prior 6 months.
• Active peptic ulcer or has had upper gastrointestinal (GI) bleeding within the prior 6 months.

Sponsors & Collaborators

• Sarepta Therapeutics, Inc.: lead
• Baim Institute for Clinical Research: collaborator

Study Sites (3)

Coburg Hospital - Cardiology Clinic

Coburg, Germany

Location

Cardiology Clinic, University Hospital of Essen

Essen, Germany

Location

University Hospital of Heidelberg, Cardiology Clinic

Heidelberg, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Restenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Coronary Stenosis

Study Officials

• Stefan Sack, MD

  Cardiac Clinic, University of Essen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 2005
• First Posted: November 3, 2005
• Study Start: September 1, 2005
• Last Updated: February 8, 2007

Record last verified: 2007-02

Locations

DE (3)