NCT00963690

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the CloSys Hemostatic Device designed to stop bleeding after an interventional procedure.

Trial Health

57
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 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 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, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 21, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2013

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

3.7 years

First QC Date

August 12, 2009

Last Update Submit

January 30, 2017

Conditions

Sealing the Arteriotomy

Outcome Measures

Primary Outcomes (2)

  • Time to hemostasis

    1 Hour

  • Time to ambulation

    6 Hours

Secondary Outcomes (1)

  • Adverse events

    Within 30 days after procedure

Study Arms (2)

CloSys HD with standard compression

EXPERIMENTAL

CloSys Arm

Device: CloSys Hemostatic Device (HD)Procedure: Standard compression

Standard compression alone

ACTIVE COMPARATOR

Manual compression arm

Procedure: Standard compression

Interventions

CloSys Hemostatic Device (HD)DEVICE

Deploy CloSys HD to achieve hemostasis

CloSys HD with standard compression
Standard compressionPROCEDURE

Use standard compression to achieve hemostasis

CloSys HD with standard compressionStandard compression alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All answers must be YES to be eligible for the study:
  • Subject is ≥ 18 years of age;
  • Subject is willing and able to provide informed consent;
  • Subject is able to ambulate pre-procedure without difficulty;
  • Subject is able to remain supine for an extended period of time;
  • Subject is willing and able to comply with the requirements of the study protocol, including all follow-up visit evaluations;

You may not qualify if:

  • All answers must be NO to be eligible for the study:
  • Subject has a systolic blood pressure (SBP) ≥ 160 mmHg despite medical therapy;
  • Subject has a diastolic blood pressure (DBP) ≥ 100 mmHg despite medical therapy;
  • Subject has received thrombolytic therapy, such as streptokinase, urokinase, retavase, tenecteplase, or tPA, within 24 hours of the scheduled procedure;
  • Subject is lactating;
  • Subject has a life expectancy of less than one (1) year;
  • The percutaneous intervention was an emergent procedure;
  • Subject has a known coagulopathy disorder, including, but not limited to, hemophilia, sickle cell disease, or von Willebrand disease;
  • Subject has a known diagnosis of an auto-immune disease;
  • Subject has a known or suspected diagnosis of vasculitis;
  • Subject currently has an infection of any kind;
  • Subject does not have either a posterior Tibialis (PT) or dorsalis pedis (DP) pulse by doppler in ipsilateral extremity;
  • Subject has critical limb ischemia and/or severe peripheral vascular disease as identified by rest pain and/or gangrene;
  • Rutherford category five (5) or six (6);
  • Subject is currently or within the last thirty (30) days participating in another investigational drug or device study;
  • +47 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cardiovascular Institute of the South

Lafayette, Louisiana, 70506, United States

Location

Rex Healthcare - Rex Heart and Vascular Research

Raleigh, North Carolina, 27607, United States

Location

Study Officials

  • George Adams, MD

    Rex Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2009

First Posted

August 21, 2009

Study Start

August 1, 2009

Primary Completion

April 30, 2013

Study Completion

May 30, 2013

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations

US(2)