AzTrials
AzTrials

ThrombolysisNCT03166059

CaveoVasc Thrombolysis Protection System, Access Protection Study

A study testing CaveoVasc® Thrombolysis Protection System in people with Thrombolysis, run by CaveoMed GmbH.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The CaveoVasc Thrombolysis Protection System is intended to aid sheath access and reduce bleeding complications during catheter directed thrombolysis (CDT) in the treatment of limb ischemia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thrombolysis
What is being tested?
CaveoVasc® Thrombolysis Protection System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Jan 2018to Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults > 18 years
  • Diagnosis of limb ischemia requiring CDT
  • Patient understands and signs the study specific written informed consent form

Who cannot join

  • Patients who are currently participating in another clinical trial of an investigational drug or device that has not concluded the follow-up period
  • Patients who cannot adhere to or complete the investigational protocol for any reason
  • Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance)
  • Patients with bleeding disorders such as thrombocytopenia (platelet count<100,000/mm3), hemophilia, von Willebrand's disease or anemia (Hgb <10g/ dL, Hct < 30%)
  • Patients who need a puncture needle longer than 8 cm due to morbid obesity
  • Patients who are cachectic and do not have enough subcutaneous tissue/fat to accommodate the CaveoMed device (the two balloons, with 2 ml of contrast-enriched saline in each ballon)
  • Patients who are pregnant or lactating
  • Patients with documented INR > 1.5 or patients currently receiving glycoprotein IIb/IIIa platelet inhibitors, unless the glycoprotein IIb/IIIa platelet inhibitor is given as a bolus prior to the CDT as part of the institution's standard of care

About this study

Official title: Prospective, Single Arm, Study to Assess the Safety and Performance of the CaveoVasc® Thrombolysis Protection System, for Femoral Artery Access and Protection in Patients Treated With Thrombolysis for Limb Ischemia

The CaveoVasc Thrombolysis Protection System is intended to aid sheath access and reduce bleeding complications during catheter directed thrombolysis (CDT) in the treatment of limb ischemia. This device has been designed to protect the puncture site by stabilizing the CDT sheath with the double-balloons that are part of the CaveoVasc system. Also the device is designed to reduce bleeding at the puncture site during CDT.

This study is designed to assess the safety and performance of the CaveoVasc Thrombolysis Protection System in twenty patients with limb ischemia undergoing treatment with CDT.

Read the detailed description

Catheter directed thrombolysis (CDT) is a non-surgical option for many patients, which involves the insertion of an infusion catheter (via the femoral artery) into the thrombus allowing for slow delivery of a pharmacological thrombolytic agent. Insertion of the infusion catheter is performed in the catheterization laboratory. The patient is usually then transferred to the intensive care unit, with delivery catheter in place and the infusion running for at least 24 hours.

The major complications reported with CDT include major and minor bleeding, and complications secondary to early termination of the CDT due to access site bleeding.

CaveoMed developed the CaveoVasc® Thrombolysis Protection System, a vascular access protection device intended for use in thrombolysis procedures. Its function is to facilitate sheath access, and minimize risks of access site bleeding complications during lengthy catheter-directed thrombolysis procedures. Pressure balloons inflated outside the artery maintain a good seal throughout thrombolysis, which typically lasts up to 24 hours. The thrombolysis catheter is then removed, and hemostasis at the site is managed per the hospital's standard.

The CaveoVasc® Thrombolysis Protection System design has important advantages for use during CDT procedures (which require long catheter dwell times). The system is intended to protect from intra-procedural bleeding at the arterial access site, which currently remains a major problem for patients with critical limb ischemia undergoing CDT treatment. This protection would lower the rate of bleeding events, and increase the rate of completed intended therapy, without interruption of the CDT treatment due to bleeding complications.

Conditions
Thrombolysis
Being tested
CaveoVasc® Thrombolysis Protection System
Keywords
Catheter directed thrombolysis (CDT)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CaveoVasc® Thrombolysis Protection SystemDevice

    CaveoVasc® Thrombolysis Protection System for Femoral Artery Access and Protection in Patients Treated with Thrombolysis for Limb Ischemia

Study groups in NCT03166059
Study groupRoleWhat they receive
Single armExperimentalCaveoVasc® Thrombolysis Protection System
Receives: Device: CaveoVasc® Thrombolysis Protection System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of all major bleeds from the start of the CDT procedure to the end of the CDT procedure

    BARC type > 3, as follows:

    Type 3 Type 3a Overt bleeding plus hemoglobin drop of 3 to <5 g/dL* (provided hemoglobin drop is related to bleed). Any transfusion with overt bleeding.

    Type 3b Overt bleeding plus hemoglobin drop >5 g/dL* (provided hemoglobin drop is related to bleed), cardiac tamponade, bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid), bleeding requiring intravenous vasoactive agents.

    Type 3c Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal), subcategories confirmed by autopsy or imaging or lumbar puncture, intraocular bleed compromising vision.

    (Type 4: CABG-related bleeding is not applicable for this study) Type 5: fatal bleeding Type 5a Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious Type 5b Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation.

    Measured: Start of the CDT procedure to the end of the CDT procedure (usually less than 48 hours)

  2. Duration of CDT procedure

    Hours

    Measured: Start of the CDT procedure to the end of the CDT procedure (usually less than 48 hours)

Secondary outcomes (5)

  1. Adverse Events at Discharge

    Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.

    Measured: From consent to discharge (usually less than 48 hours from start of procedure)

  2. Adverse Events at 30 days

    Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.

    Measured: At 30 follow-up visit

  3. CDT without early interruption due to access site complication

    Rate

    Measured: Start to end of CDT procedure (usually less than 48 hours from start of procedure)

  4. Successful thrombolysis

    Rate of successful thrombolysis without bleeding complication

    Measured: Start to end of CDT procedure (usually less than 48 hours from start of procedure)

  5. Pain at access site

    verbal pain scale (0 to 10), at start of CDT (time when infusion of lysis medication started), after 6 hours of start of CDT, and at the end of the CDT treatment (time when infusion of lysis medication has stopped)

    Measured: Start to end of lysis medication (usually less than 48 hours from start of procedure)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2017
  2. Study startJan 2018 (estimated)
  3. Primary completionJan 2018 (estimated)
  4. Study completionFeb 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03166059
Sponsor's protocol ID
Caveomed-2017-05
Status last verified
May 2017
First submitted
22 May 2017
Last updated
22 Dec 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CaveoVasc® Thrombolysis Protection System in people with Thrombolysis, run by CaveoMed GmbH.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of all major bleeds from the start of the CDT procedure to the end of the CDT procedure (time frame: Start of the CDT procedure to the end of the CDT procedure (usually less than 48 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03166059.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in