Skip to main content
OpenTrials
Completed

NCT Number: NCT00196105

Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)

This study compares the 6 mm nitinol Zilver biliary endoprostheses and the 10 mm nitinol Zilver biliary endoprostheses to the 10 mm Wallstent in appropriate patients in need of palliative treatment of malignant obstructive jaundice.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Biliary Tract Neoplasms Biliary Tract Diseases Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hyperbilirubinemia Jaundice Jaundice, Obstructive Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maine Medical Center

Portland, Maine, 04102, United States

About this study

This research is being done to determine if the new, FDA-cleared Zilver metal biliary stent is better than the conventional stents. The new Zilver stent may permit more accurate placement, may avoid some potential complications and last longer than the conventional stents. The study will also examine to find the best diameter of stent by comparing standard 10 mm stents to 6 mm Zilver stents.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unresectable malignancy of the extrahepatic bile duct

Exclusion criteria

  • Age below 21 years
  • Pregnancy
  • Active alcohol or drug abuse
  • Simultaneously participating in another investigational drug or device study.
  • Allergy to stainless steel or nitinol
  • Active cholangitis
  • Brachytherapy
  • Unable or unwilling to comply with follow up

Treatment and study plan

6 mm Nitinol Zilver Stent

Device

10 mm Nitinol Zilver Stent

Device

10 mm Stainless Steel Wallstent

Device

Primary outcomes

  1. Patency

    Time frame: up to 32 months

    Number of days of stent patency: The time to stent occlusion requiring re-intervention, death, loss to follow-up, or patients alive at study end without an occlusion (>= 6 months after placement).

  2. Closure or Blockage of the Stent (Occlusion)

    Time frame: up to 32 months

    Biliary stents may become closed or blocked. This is also termed "Occlusion." Data for this outcome measure involve stent occlusions that required re-intervention.

  3. Number of Days to Occlusion

    Time frame: up to 32 months

  4. Number of Deaths

    Time frame: up to 32 months

  5. Time to Death

    Time frame: up to 32 months

    Overall Survival

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

Multicenter Prospective Randomized Controlled Trial of the Nitinol ZILVER Expandable Endoprosthesis in the Palliation of Extrahepatic Malignant Biliary Obstruction

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Oct 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.