Peripheral Arterial DiseasePhase 2TAP-DANCENCT03942601
Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization
A Phase 2 study testing Temsirolimus and Temsirolimus and dexamethasone sodium phosphate in people with Peripheral Arterial Disease, run by Mercator MedSystems, Inc. at 11 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Temsirolimus and Temsirolimus and dexamethasone sodium phosphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 11 sitesUnited States
- Study dates
- 1 Oct 2019to 30 Apr 2021
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University Hospital
Cleveland, Ohio, 44106
University of Colorado
Denver, Colorado, 80045
Rocky Mountain Veterans Administration Hospital
Denver, Colorado, 80220
Baylor College of Medicine
Houston, Texas, 77030
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Columbia University Medical Center/NYPH
New York, New York, 10032
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
St. Joseph Hospital of Orange Heart and Vascular Center
Orange, California, 92868
Einstein Medical Center
Philadelphia, Pennsylvania, 19141
North Carolina Heart and Vascular
Raleigh, North Carolina, 27607
San Francisco VA Medical Center
San Francisco, California, 94121
About this study
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.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Temsirolimus, Temsirolimus and dexamethasone sodium phosphate
- 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.
TemsirolimusDrug
Temsirolimus Injection (0.4 mg/mL) and 20% contrast in Group 1
Temsirolimus and dexamethasone sodium phosphateDrug
Temsirolimus Injection (0.4 mg/mL), Dexamethasone Sodium Phosphate Injection, USP (3.2 mg/mL) and 20% contrast in Group 2
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - temsirolimus injection | Active comparator | Temsirolimus Injection (0.4 mg/mL) and 20% contrast in Group 1 Receives: Drug: Temsirolimus |
| Group 2 - temsirolimus and dexamethasone injection | Active comparator | Temsirolimus Injection (0.4 mg/mL), Dexamethasone Sodium Phosphate Injection, USP (3.2 mg/mL) and 20% contrast in Group 2 Receives: Drug: Temsirolimus and dexamethasone sodium phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Freedom from MALE-POD at 30 days
Freedom from MALE-POD at 30 days
Measured: 30 days post intervention
Effectiveness - Primary patency
Primary patency (adjudicate by angio core lab)
Measured: 12 months post intervention
Effectiveness - Freedom from CD-TLR
Freedom from clinically driven target lesion revascularization (CD-TLR)) at 12 months.
Measured: 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start1 Oct 2019
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Why it stopped: Halted due to pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercator MedSystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942601
- Sponsor's protocol ID
- CIP0215
- Acronym
- TAP-DANCE
- Status last verified
- Jul 2024
- First submitted
- 6 May 2019
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization
- ClinicalTrials.gov ID
- NCT03942601
- Acronym / sponsor ID
- TAP-DANCE / CIP0215
- Conditions
- Peripheral Arterial Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Halted due to pandemic.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mercator MedSystems, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 - temsirolimus injection | Active comparator | Drug: TemsirolimusTemsirolimus Injection (0.4 mg/mL) and 20% contrast in Group 1 |
| Group 2 - temsirolimus and dexamethasone injection | Active comparator | Drug: Temsirolimus and dexamethasone sodium phosphateTemsirolimus Injection (0.4 mg/mL), Dexamethasone Sodium Phosphate Injection, USP (3.2 mg/mL) and 20% contrast in Group 2 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TemsirolimusTemsirolimus Injection (0.4 mg/mL) and 20% contrast in Group 1 | Drug | Group 1 - temsirolimus injection |
| Temsirolimus and dexamethasone sodium phosphateTemsirolimus Injection (0.4 mg/mL), Dexamethasone Sodium Phosphate Injection, USP (3.2 mg/mL) and 20% contrast in Group 2 | Drug | Group 2 - temsirolimus and dexamethasone injection |
Primary outcome
Safety - Freedom from MALE-POD at 30 days
Time frame: 30 days post intervention
Freedom from MALE-POD at 30 days
Effectiveness - Primary patency
Time frame: 12 months post intervention
Primary patency (adjudicate by angio core lab)
Effectiveness - Freedom from CD-TLR
Time frame: 12 months post intervention
Freedom from clinically driven target lesion revascularization (CD-TLR)) at 12 months.
Results and safety
The study was stopped early (reason given: Halted due to pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temsirolimus and Temsirolimus and dexamethasone sodium phosphate in people with Peripheral Arterial Disease, run by Mercator MedSystems, Inc. at 11 sites 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 21 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 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Halted due to pandemic.). 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?
Safety - Freedom from MALE-POD at 30 days (time frame: 30 days post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2024.