NCT00733070

Brief Summary

A multicenter multinational study to evaluate the safety and efficacy of the CiTop™ ExPander™ Guidewire for crossing chronic total occlusion in Coronary arteries.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 9, 2013

Status Verified

July 1, 2013

Enrollment Period

4.8 years

First QC Date

August 10, 2008

Last Update Submit

July 6, 2013

Conditions

Coronary Chronic Total Occlusion

Keywords

CTOChronic Total OcclusionRevascularization

Outcome Measures

Primary Outcomes (1)

  • Angiographic documentation of placement of CiTop™ distal to occlusion with no device related major complications

    during procedure, 1day, 1week and 30 days post procedure

Secondary Outcomes (6)

  • Successful stenting

    During procedure, Day1, Day7 and Day30 post procedure

  • Wire crossing duration

    during procedure

  • Fluoroscopy time

    during procedure

  • Amount of contrast

    during procedure

  • Maneuverability of the CiTop™ up to the occlusion

    during procedure

  • +1 more secondary outcomes

Interventions

CiTop™ ExPander™ GuidewireDEVICE

Chronic Total Occlusion guidewire

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent obtained prior to any trial activities.

You may not qualify if:

  • Patient has an angiographic documented Chronic Total Occlusion showing distal TIMI flow 0 to 1.
  • Patient unable to give informed consent.
  • Current participation in another study with any investigational drug or device.
  • Factors making follow-up and/or repeat angiography difficult or unlikely.
  • Contra-indication to emergency artery by pass surgery.
  • Lack of surgical backup.
  • Contra-indication to treatment with Aspirin, or Clopidogrel and/or Heparin.
  • Lesion \> 40mm in length (both calcified lesion and adjacent thrombus).
  • Treated vessel referenced diameter less than 2.5 mm.
  • Visualization of the distal lumen less than the Rentrop Classification Grade 2 collateralization.
  • Non-visible entry point of target lesion.
  • Totally occluded bypass graft as target vessel.
  • Acute MI less than 1 week before procedure.
  • Patient has significant LV dysfunction, 35% LVEF or less.
  • Patient with cancer or other sever chronic disease with life expectance of 2 years.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

HELIOS Klinikum Wuppertal

Wuppertal, D-42117, Germany

Location

Sunward Park Hospital

Boksburg, South Africa

Location

Sunninghill Hospital

Sunninghill, 2157, South Africa

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 10, 2008

First Posted

August 12, 2008

Study Start

August 1, 2008

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

July 9, 2013

Record last verified: 2013-07

Locations

DE(1)ZA(2)