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Peripheral Artery DiseaseFORTEZNCT03676842

Prospective Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral And/or Popliteal Arteries Using the FLEX Scoring Catheter Plus DCB

A study testing FLEX Dynamic Scoring Catheter with IN.PACT Admiral DCB in people with Peripheral Artery Disease, run by VentureMed Group Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Prospective, single-center, single-arm, non-randomized study to assess the safety and efficacy of the FLEX Scoring Catheter in patients with atherosclerotic peripheral artery disease in the superficial femoral and popliteal arteries. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Artery Disease
What is being tested?
FLEX Dynamic Scoring Catheter with IN.PACT Admiral DCB
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
11 Oct 2018to 23 Sep 2020
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

  • Women of child-bearing potential must have a negative test within 7 days of the initial procedure
  • Patient or patient's legal representative has been informed of the nature of the study, agrees to participate and comply with all follow-up visits, and has signed the informed consent.
  • Patient is eligible for standard surgical repair in the target limb if necessary.
  • Patient has Rutherford Clinical Category estimated as 2-6.
  • A life expectancy >1 year.
  • Angiographic Inclusion Criteria:
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  • Target lesion(s) is located within the SFA and/or the popliteal arteries.
  • Target lesion has >70% stenosis by visual assessment.
  • The reference vessel diameter is between 4-6 mm.
  • One long or multiple serial lesions.
  • de novo or non-stented re-stenotic lesions.
  • At least one BTK artery patent to the ankle.
  • Successful treatment of iliac inflow stenosis to the target limb. Stenosis can be treated during the same procedure using standard angioplasty and/or stenting but atherectomy is excluded. The inflow lesion(s) must be treated first, before consideration of treatment of the target lesion. Subject can be enrolled if the treated inflow lesion(s) results in <30% residual stenosis and no evidence of embolization or significant complications.

Who cannot join

  • Rutherford Clinical Category 1.
  • Previously implanted ipsilateral femoral or popliteal stent.
  • Evidence of aneurysm or acute thrombus in the target vessel.
  • Patients with previous bypass surgery in the lower target extremity.
  • Planned major amputation, above the ankle, of either limb.
  • Patient has significant stenosis or occlusion of inflow tract not successfully treated (>30% residual stenosis and/or significant complication of the procedure)
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  • History of any open surgical procedure within the past 30 days
  • Planned endovascular or vascular surgery procedure within 14 days prior to the ATK procedure, except to treat the inflow vessels on the day of the procedure, or within the next 30 days after the ATK procedure on the target limb.
  • Patient has an allergy to contrast medium that cannot be adequately pretreated.
  • Episode of acute limb ischemia within the past 30 days.
  • Patient has systemic infection with positive blood cultures/bacteremia within one week
  • Patient has hypercoagulable disorder.
  • Patient is contraindicated for antiplatelet, anticoagulant, or thrombolytic therapy.
  • Myocardial infarction within 30 days prior to enrollment.
  • History of stroke or TIA within 90 days prior to enrollment.
  • Patient has acute or chronic renal disease (i.e., as measured by a serum creatinine of >2.5 mg/dL or >220 umol/L)
  • Patient is pregnant or breastfeeding
  • Patient is participating in another research study of a device, medication, which could, in the opinion of the investigator, affect the results of this study.
  • Patient has other medical, social, or psychological problems that in the opinion of the investigator, would preclude them from receiving this treatment and the procedure and or participating in evaluations pre- and post-treatment.
  • Thrombolysis of the target lesion within 72 hours prior to the initial procedure, where complete resolution of the thrombus was not achieved.
  • Known allergies to both antiplatelet, aspirin, or heparin.
  • History of neutropenia, coagulopathy, or thrombocytopenia that was unexplained or is considered to be a risk for reoccurrence.
  • Platelet count less than 80,000/uL
  • Patient requires general anesthesia for procedure.
  • Patient requires dialysis.
  • Angiographic Exclusion Criteria:
  • Acute Total Occlusions; evidence of acute thrombus formation by angiography.
  • Severe calcification of target lesion described as circumferential calcium and >50% of lesion length.
  • Sub-intimal access required.
  • Inability to cross the lesion with a guidewire.
  • Atherectomy in the target lesion, target artery or for inflow treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Saint Joseph Hospital

    Fort Wayne, Indiana, 46802

Other trials in United States

About this study

Prospective, single-center, single-arm, non-randomized study to assess the safety and efficacy of the FLEX Scoring Catheter in patients with atherosclerotic peripheral artery disease in the superficial femoral and popliteal arteries.

Being tested
FLEX Dynamic Scoring Catheter with IN.PACT Admiral DCB
Medical subject headings
Peripheral Arterial Disease

What participants receive

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

  • FLEX Dynamic Scoring Catheter with IN.PACT Admiral DCBCombination product

    Treatment by the FLEX Scoring Catheter followed by an IN.PACT Admiral DCB

Study groups in NCT03676842
Study groupRoleWhat they receive
FLEX Scoring Catheter plus DCBExperimentalThis is a single-arm study. All patients will be treated with the FLEX Scoring Catheter followed by an IN.PACT Admiral Drug-Coated Balloon (Medtronic Vascular; Galway, Ireland).
Receives: Combination Product: FLEX Dynamic Scoring Catheter with IN.PACT Admiral DCB

What is being measured

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

  1. Technical feasibility of the FLEX Scoring Catheter

    Evaluation of the technical feasibility of using the FLEX Scoring Catheter during the endovascular treatment of critical SFA or popliteal artery lesions.

    Measured: Through study completion: Approximately 12 months

Secondary outcomes (8)

  1. Absence of lesion restenosis

    Defined by PSVR ≥ to 2.5 at duplex scan

    Measured: 6 and 12 months

  2. Change in Rutherford Class of symptom

    Measured: 6 and 12 months

  3. Change in ankle-brachial index (ABI)

    Measured: 6 and 12 months

  4. Absence of clinically driven target vessel revascularization

    Measured: 12 months

  5. Major adverse events (MAE)

    Measured: at procedure, 6 months, and 12 months

  6. Proportion of luminal gain

    Measured: at procedure

  7. Proportion of stent implantation

    Measured: at procedure

  8. Proportions and classifications of dissections

    Measured: at procedure

Timeline

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

  1. First posted19 Sep 2018
  2. Study start11 Oct 2018
  3. Primary completion23 Sep 2020
  4. Study completion23 Sep 2020

Why it stopped: Low enrollment- Hospital during COVID

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03676842
Sponsor's protocol ID
The FORTEZ Study
Acronym
FORTEZ
Status last verified
Nov 2024
First submitted
17 Sep 2018
Last updated
26 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing FLEX Dynamic Scoring Catheter with IN.PACT Admiral DCB in people with Peripheral Artery Disease, run by VentureMed Group Inc. at 1 site in United States.

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 13 inclusion and 31 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: stopped early, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study was stopped early (reason given: Low enrollment- Hospital during COVID). 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?

Technical feasibility of the FLEX Scoring Catheter (time frame: Through study completion: Approximately 12 months). 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 NCT03676842.

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 26 Nov 2024.

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