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

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ClinicalTrials.gov Identifier: NCT03942601
Recruitment Status : Not yet recruiting
First Posted : May 8, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Mercator MedSystems, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Drug: Temsirolimus Drug: Temsirolimus and dexamethasone sodium phosphate Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

This is an open-label study without randomization. Cohorts will be enrolled sequentially, with Group 1 followed by Group 2.

Study Drug: Temsirolimus Injection (0.4 mg/mL) and 20% contrast in Group 1 or Temsirolimus Injection (0.4 mg/mL), Dexamethasone Sodium Phosphate Injection, USP (3.2 mg/mL) and 20% contrast in Group 2 Route of Administration: Bullfrog Micro-Infusion Device adventitial delivery Dosage Volume:0.5 mL per cm of target vessel length Up to 30 subjects in Group 1 and up to 30 subjects in Group 2. The study shall enroll subjects from up to 20 sites in the United States.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : August 15, 2024


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




Primary Outcome Measures :
  1. Safety - Freedom from MALE-POD at 30 days [ Time Frame: 30 days post intervention ]
    Freedom from MALE-POD at 30 days

  2. Effectiveness - Primary patency [ Time Frame: 12 months post intervention ]
    Primary patency (adjudicate by angio core lab)

  3. Effectiveness - Freedom from CD-TLR [ Time Frame: 12 months post intervention ]
    Freedom from clinically driven target lesion revascularization (CD-TLR)) at 12 months.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942601


Contacts
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Contact: Kirk Seward, PhD (510) 614-4555 kseward@mercatormed.com

Locations
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United States, Arkansas
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
United States, California
St. Joseph Hospital of Orange Heart and Vascular Center
Orange, California, United States, 92868
San Francisco VA Medical Center
San Francisco, California, United States, 94121
United States, Colorado
Rocky Mountain Veterans Administration Hospital
Denver, Colorado, United States, 80220
United States, Illinois
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
United States, North Carolina
North Carolina Heart and Vascular
Raleigh, North Carolina, United States, 27607
United States, Ohio
University Hospital
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Mercator MedSystems, Inc.

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Responsible Party: Mercator MedSystems, Inc.
ClinicalTrials.gov Identifier: NCT03942601     History of Changes
Other Study ID Numbers: CIP0215
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dexamethasone 21-phosphate
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Sirolimus
Dexamethasone
Dexamethasone acetate
Everolimus
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Anti-Bacterial Agents