PolyArginine Treated vEiN grafTs (PATENT)

NCT00264706 | Terminated Phase 1

• 1 other identifier: Lumen-01-CS-1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objectives of this trial are: 1) to evaluate the safety of NONA-L-ARGININE in ex vivo application to saphenous vein segments prior to grafting; and, 2) to obtain preliminary data on the biological effects of NONA-L-ARGININE, as compared to placebo, in the prevention of neointimal hyperplasia.

Conditions

Saphenous Vein Graft Disease

Outcome Measures

Primary Outcomes (2)

• Safety - as assessed by the nature and frequency of clinical adverse event at 6 weeks post-surgery.

  6 weeks

• Efficacy - Volume obstruction of the vein grafts measured by IVUS at 1 year.

  1 year

Secondary Outcomes (1)

• 1. Volume obstruction adjacent to the proximal and distal anastomoses, and within the body of the graft; 2. Intima:media ratio; 3. Minimal and maximal luminal diameter; and, 4. lumen volume:vessel volume.

  1 year

Study Arms (1)

Participant

OTHER

Internal control study

Drug: Nona-L-arginine

Interventions

Nona-L-arginine DRUG

Participant

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be 35-85 years of age and able to give informed consent.
• Coronary artery disease requiring bypass grafting using at least two saphenous vein bypass grafts carried out through median sternotomy and utilizing cardiopulmonary bypass.
• Use of an approved statin anticipated for at least 24 months after surgery.
• Subject must not be a candidate for concurrent ventricular surgical restoration, AICD placement, or valvular surgery.
• Agreeable to CTA at 6 weeks and IVUS intervention at 12-months post-CABG. Subjects agreeable to additional CTA at 6, 12 and 24 months preferred.

You may not qualify if:

• Acute traumatic injury or vasculitis.
• Insulin-dependent diabetes.
• Procedure is for revision for an existing bypass graft.
• Procedure is to be minimally invasive (except for harvesting of the graft segment).
• Concurrent cardiac valvular surgery.
• Patients with any medical condition that, in the investigator's judgment, makes the patient ineligible or places the patient at undue risk (e.g. conditions that preclude standard invasive follow-up procedures such as IVUS and angiography, i.e. renal failure, bleeding diathesis, or peripheral vascular disease preventing catheterization via the groin).
• Subject has clinical evidence of infection that the Investigator deems significant to the completion of the procedure, or that could compromise the subject's safety.
• Subject has recent history (within past 6 months) of alcohol or drug abuse.
• If female, subject is pregnant or trying to become pregnant.
• Calculated creatinine clearance \< 30 mls/min for non-diabetics or \< 50 mls/min for non-insulin dependent diabetics.

Sponsors & Collaborators

• Lumen Therapeutics: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Links

• Click here for additional information on Saphenous Vein Graft Disease and the PATENT study.

MeSH Terms

Interventions

nonaarginine

Study Officials

• Stephanie Brister, M.D.

  Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2005
• First Posted: December 13, 2005
• Study Start: March 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: September 8, 2016

Record last verified: 2016-09

Locations

CA (1)