Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT01321073 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.
Minor2 versionsRe-verified since Jul 30, 2025, no change to tracked fieldsv31-v32
MinorSite details revised at 1 of 8 sitesv30
MinorStudy sites: 9 to 8
Eligibility criteria expanded, about 4 words
v29
MinorStudy sites: 10 to 9
Eligibility criteria shortened, about 435 words
Study title expanded, about 4 words
v28
MinorStudy completion date: Nov 2022 to Dec 2032v27
Show 25 earlier versionsHide 25 earlier versions
MinorPublications: 2 to 5v26
MinorRe-verified, no change to tracked fieldsv25
MinorStudy completion date: Nov 2021 to Nov 2022
Collaborators expanded, about 2 words
v24
Minor2 versionsRe-verified since Sep 19, 2019, no change to tracked fieldsv22-v23
MinorStudy completion date: Mar 2019 to Nov 2021v21
MinorStudy sites revised (10)v20
NotableResults first posted: May 4, 2018
Study completion date: Jan 2016 to Mar 2019
Primary endpoint revised
v19
MinorStudy completion date: Jan 2015 to Jan 2016
Interventions: The Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System to deliver… to Model 10642 Implantable Intravascular Catheter (Device)
v18
MinorRe-verified, no change to tracked fieldsv17
MinorPrimary completion date changed from estimate of Oct 2013 to Jun 2013v16
MinorStudy description expanded, about 102 wordsv15
MinorTrial status: Recruiting to Active, Not Recruiting
Enrollment target: estimated 70 to confirmed 64
Site details revised at 10 of 10 sites
v14
MinorSite details revised at 9 of 10 sites
Study arms: 0 to 1
v13
MinorStudy sites: 9 to 10
Primary completion date: Jul 2013 to Oct 2013
Study completion date: Jul 2014 to Jan 2015
v12
MinorStudy sites: 8 to 9v11
NotableTrial status: Suspended to Recruiting
Study sites: 6 to 8
v10
StoppedTrial status: Recruiting to SuspendedSponsor's reason: Subject enrollments have been temporarily suspended pending evaluation of the implant procedure.
Site details revised at 6 of 6 sites
v9
MinorStudy sites: 5 to 6
Study completion date: Apr 2014 to Jul 2014
v8
MinorStudy sites: 4 to 5
Primary completion date: Oct 2013 to Jul 2013
v7
MinorStudy sites: 3 to 4v6
MinorStudy sites: 2 to 3v5
MinorStudy sites: 1 to 2v4
NotableTrial status: Not Yet Recruiting to Recruiting
Study sites: 0 to 1
v3
NotableStart date: Apr 2011 to Jun 2011
Study completion date: Dec 2014 to Apr 2014
v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of the DelIVery for PAH clinical study is to evaluate the safety of the Medtronic Model 10642 Implantable Intravascular Catheter when used with the Medtronic SynchroMed® II Implantable Infusion System to deliver Remodulin® (treprostinil) Injection.
As of June 2021, PMA approval of the Implantable System for Remodulin (ISR) is no longer being pursued and development and commercialization efforts have been halted. The approximately 30 subjects still implanted with the PIVoT system require a pathway for continued support. This protocol is amended and is designed to allow such ongoing support.