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

NCT03676842 | Terminated FDA Device

• 1 other identifier: The FORTEZ Study
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (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.

  Through study completion: Approximately 12 months

Secondary Outcomes (8)

• Absence of lesion restenosis

  6 and 12 months

• Change in Rutherford Class of symptom

  6 and 12 months

• Change in ankle-brachial index (ABI)

  6 and 12 months

• Absence of clinically driven target vessel revascularization

  12 months

• Major adverse events (MAE)

  at procedure, 6 months, and 12 months

Study Arms (1)

FLEX Scoring Catheter plus DCB

EXPERIMENTAL

This 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).

Combination Product: FLEX Dynamic Scoring Catheter with IN.PACT Admiral DCB

Interventions

FLEX Dynamic Scoring Catheter with IN.PACT Admiral DCB COMBINATION_PRODUCT

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

FLEX Scoring Catheter plus DCB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• VentureMed Group Inc.: lead

Study Sites (1)

Saint Joseph Hospital

Fort Wayne, Indiana, 46802, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Louis Lopez, MD

  Allen County Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 19, 2018
• Study Start: October 11, 2018
• Primary Completion: September 23, 2020
• Study Completion: September 23, 2020
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)