Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization

Peripheral Arterial Disease Clinical Trial

— TAP-DANCE  

Official title:

Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03942601
• Other study ID #: CIP0215
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2019
• Est. completion date: August 15, 2024

Study information

• Verified date: August 2020
• Source: Mercator MedSystems, Inc.
• Contact: Kirk Seward, PhD
• Phone: (510) 614-4555
• Email: kseward[@]mercatormed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 15, 2024
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Drug:
• Temsirolimus
Temsirolimus Injection (0.4 mg/mL) and 20% contrast in Group 1
• 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

Locations

Country	Name	City	State
United States	University Hospital	Cleveland	Ohio
United States	Rocky Mountain Veterans Administration Hospital	Denver	Colorado
United States	University of Colorado	Denver	Colorado
United States	Baylor College of Medicine	Houston	Texas
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	Columbia University Medical Center/NYPH	New York	New York
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	St. Joseph Hospital of Orange Heart and Vascular Center	Orange	California
United States	Einstein Medical Center	Philadelphia	Pennsylvania
United States	North Carolina Heart and Vascular	Raleigh	North Carolina
United States	San Francisco VA Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Mercator MedSystems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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