Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization (TAP-DANCE)

August 31, 2020 updated by: Mercator MedSystems, Inc.
This is a prospective, multi-center, pilot feasibility study to document the effects of adventitial delivery of temsirolimus or temsirolimus with dexamethasone sodium phosphate injection, USP, after revascularization of femoropopliteal lesions in symptomatic patients with moderate to severe claudication (Rutherford 2-3) or critical limb ischemia (CLI) with rest pain (Rutherford 4). Subjects will be followed for up to 60 months post index procedure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To begin to assess the safety and effectiveness of Bullfrog Micro-Infusion Device adventitial deposition of temsirolimus or temsirolimus with dexamethasone in maintaining luminal patency and composite safety endpoints in patients with clinical evidence of moderate to severe claudication or critical limb ischemia with rest pain after revascularization of one or more angiographically significant lesion(s) in superficial femoral or popliteal arteries.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Arkansas Heart Hospital
        • Contact:
        • Principal Investigator:
          • Ian Cawich, MD
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • St. Joseph Hospital of Orange Heart and Vascular Center
        • Contact:
        • Principal Investigator:
          • Mahmood K. Razavi, MD
      • San Francisco, California, United States, 94121
        • Active, not recruiting
        • San Francisco VA Medical Center
    • Colorado
      • Denver, Colorado, United States, 80045
      • Denver, Colorado, United States, 80220
        • Recruiting
        • Rocky Mountain Veterans Administration Hospital
        • Contact:
        • Principal Investigator:
          • Ehrin J Armstrong, MD MSc FACC FSCAI FSVM
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Recruiting
        • Advocate Christ Medical Center
        • Principal Investigator:
          • Jaafer Golzar, MD
        • Contact:
    • New York
      • New York, New York, United States, 10032
        • Active, not recruiting
        • Columbia University Medical Center/NYPH
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • North Carolina Heart and Vascular
        • Contact:
        • Principal Investigator:
          • George Adams, MD
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Not yet recruiting
        • University Hospital
        • Contact:
        • Principal Investigator:
          • Medhi Shishehbor, DO, PHD, MPH
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Recruiting
        • Einstein Medical Center
        • Contact:
        • Principal Investigator:
          • Jon George, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
        • Principal Investigator:
          • Miguel Montero-Baker, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Screening Criteria:

  • Age ≥18 years and ≤85 years at study enrollment
  • Subject has been informed of the nature of the study, agrees to participate and has signed an IRB-approved consent form
  • Subject is ambulatory
  • Female subjects of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a highly effective method of birth control (See Section 12.2) for one month preceding and 12 months following study treatment
  • Subject has documented moderate to severe claudication (Rutherford 2-3) or Critical Limb Ischemia (CLI) with rest pain (Rutherford 4) in the target limb due to arterial stenosis within the superficial femoral and/or popliteal artery
  • Life expectancy >2 years in the Investigator's opinion Angiographic Criteria (Target Lesion Definition)
  • Target vessel reference diameter ≥3 mm and ≤8 mm

  • Single or multiple de novo atherosclerotic or restenotic lesion(s) with ≥70% narrowing in the superficial femoral or popliteal artery meeting the following criteria:

    • The target lesion must be ≤20 cm in total length
    • The target lesion does not have more than 5 cm of contiguous length of intervening normal artery
    • The target lesion does not cross into the common femoral artery or tibeoperoneal trunk
    • The target lesion is located at least 10 mm away from any previously placed stent or graft
  • Successful wire crossing (sub-intimal is allowed) and revascularization by balloon angioplasty of the target lesion with less than 30% residual stenosis and run-off in at least one patent vessel into the foot

Exclusion Screening Criteria:

  • Subject is already enrolled in another clinical study of systemic drug therapy or another device study that has not completed its primary endpoint
  • Subject unwilling or unlikely to comply with visit schedule
  • Subjects who are incapable of providing consent and/or incapable of understanding the nature, significance and implications of the clinical trial
  • Subject is already receiving, has received in prior 2 months, or is planned in the 6 months after index procedure to receive systemic immunotherapy, chemotherapy, or systemic steroids (however, steroid pre-treatment for contrast allergy, inhaled steroids for asthma treatment or topical steroid uses are allowed)
  • Subject is receiving chronic anticoagulation therapy e.g. warfarin (note: chronic antiplatelet therapy, e.g. aspirin and clopidigrel, and procedural anticoagulation therapy, e.g. heparin or bivalirudin, are allowed)
  • Subject has a bilirubin level of >1.5xULN
  • Recent (<30 days prior to study procedure) myocardial infarction
  • Cerebrovascular accident <60 days prior to the study procedure or any history of intracerebral hemorrhage
  • Any surgical or endovascular procedure (not including staged revascularization in the target limb, e.g. inflow revascularization prior to index procedure or below-knee revascularization after the index procedure) performed within 14 days prior to the index procedure or planned within 30 days post index procedure
  • Planned amputation in the target limb
  • Active foot infection or ischemic foot wound
  • Inability to receive temsirolimus, dexamethasone or iodinated contrast medium due to labeled contra-indications or known sensitivity reactions
  • Estimated glomerular filtration rate (eGFR, calculated from serum creatinine using an isotope dilution mass spectrometry (IDMS)-traceable equation) less than 30 mL/min Angiographic/Procedural Criteria
  • Hemodynamically significant inflow lesion (≥50% DS) or occlusion in the ipsilateral iliac artery in which there is failure to successfully treat and obtain a <30% residual stenosis post-revascularization, with bailout stenting as needed (in-flow lesions should be treated prior to treating the target lesion)
  • Prior stent placement in target lesion (i.e., in-stent restenosis)
  • Target lesion restenosis of any kind within 6 months of a prior intervention
  • Use of alternative therapy, e.g. radiation therapy, drug-eluting stents (DES) or drug-eluting balloon/drug-coated balloons (DEB/DCB) as part of the target lesion treatment during the index procedure or during the previous 12 months
  • Use of atherectomy devices in the target lesion during the index procedure
  • Aneurysm in the target vessel
  • Acute thrombus in the target limb
  • Heavy eccentric or concentric calcification at target lesion, which in the judgment of the investigator would prevent penetration of the Micro-Infusion Device needle through the vessel wall

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1 - temsirolimus injection
Temsirolimus Injection (0.4 mg/mL) and 20% contrast in Group 1
Drug: Temsirolimus
Temsirolimus Injection (0.4 mg/mL) and 20% contrast in Group 1
Active Comparator: Group 2 - temsirolimus and dexamethasone injection
Temsirolimus Injection (0.4 mg/mL), Dexamethasone Sodium Phosphate Injection, USP (3.2 mg/mL) and 20% contrast in Group 2
Drug: Temsirolimus and dexamethasone sodium phosphate
Temsirolimus Injection (0.4 mg/mL), Dexamethasone Sodium Phosphate Injection, USP (3.2 mg/mL) and 20% contrast in Group 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - Freedom from MALE-POD at 30 days
Time Frame: 30 days post intervention
Freedom from MALE-POD at 30 days
30 days post intervention
Effectiveness - Primary patency
Time Frame: 12 months post intervention
Primary patency (adjudicate by angio core lab)
12 months post intervention
Effectiveness - Freedom from CD-TLR
Time Frame: 12 months post intervention
Freedom from clinically driven target lesion revascularization (CD-TLR)) at 12 months.
12 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mercator MedSystems, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

August 15, 2024

Study Registration Dates

First Submitted

May 6, 2019

First Submitted That Met QC Criteria

May 6, 2019

First Posted (Actual)

May 8, 2019

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP0215

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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