Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01596595 · ClinicalTrials.gov registry record
Longitudinal Surveillance Study of the 4-SITE Lead/Header System
A clinical trial, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- 1,820
- Enrollment target
NCT01596595: Completed study, sponsored by Boston Scientific Corporation.
NCT01596595 is a clinical trial that has completed, run by Boston Scientific Corporation. The registered enrollment target is 1,820 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01596595 has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- 1,820 participants
- Enrollment target
Study Summary
Post-approval studies of implanted leads provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting. The goal of the study is to evaluate, document and report on the appropriate clinical performance, long-term reliability and the functional integrity of the Boston Scientific ENDOTAK RELIANCE® 4-SITE™ Lead and the pulse generator 4-SITE Header.
Primary Outcome
The 4-SITE Lead/Header System will be evaluated based on the "chronic 4-SITE Lead/Header System-related complication-free rate" for the five (5) year follow-up period after the index implantation. The primary endpoint analysis will include confirmed chronic 4-SITE Lead/Header System-related complications that result in study subject permanent loss of therapy, invasive intervention, injury or death.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,820 participants |
| Start Date | 2013-04-04 |
| Est. Completion | 2020-02-18 |
What the finished NCT01596595 record still lists
NCT01596595 is an observational study that tracks outcomes without assigning an intervention. Its 1,820 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT01596595 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01596595 about?
NCT01596595 is a clinical study titled "Longitudinal Surveillance Study of the 4-SITE Lead/Header System". Post-approval studies of implanted leads provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting. The goal of the study is to evaluate, document and report on the appropriate clinical performance, long-term reliability and the functional integ...
What is the current status of trial NCT01596595?
This trial is currently completed. The enrollment target is 1,820 participants. The study started on 2013-04-04. Estimated completion is 2020-02-18.
Who is sponsoring clinical trial NCT01596595?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05897788 · 1,808 participants · NA
Text-Messaging Telehealth and Contingency Management for Opioid Use Disorder Treatment Engagement
- NCT05935007 · 1,805 participants
Aveir DR Real-World Evidence Post-Approval Study
- NCT07104240 · 1,836 participants · NA
A Vaccine Promotion Package (TweenVax) to Improve Adolescent HPV Vaccination, TweenVax Trial
- NCT06740630 · 1,840 participants · Phase 3
A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI