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Peripheral Arterial DiseaseNCT02469532

DANCE Partner: Inflammatory Biomarker Analysis by Femoropopliteal Revascularization Method and Treatment Outcomes

An observational study of Peripheral Arterial Disease, run by Mercator MedSystems, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective, multi-center, observational registry to document the baseline, 24-hour and 30-day inflammatory response and procedural outcomes out to 12 month follow-up after femoropopliteal angioplasty or atherectomy-based revascularization procedures. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Arterial Disease
What is being tested?
Balloon Angioplasty and Atherectomy System
Type of treatment
Medical device
How many people
31 participants
Where
6 sitesUnited States
Study dates
May 2015to Jan 2018
How long will I take part?
1 Year
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Male or female at least 18 years of age presenting with a de novo or nonstented restenotic lesions >90 days from prior angioplasty and/or atherectomy of lesions causing >70% narrowing in the superficial femoral and/or popliteal arteries and totalling up to 15 cm in length (with no greater than 3 cm length of contiguous intervening normal artery), Rutherford Category 2-4, and with a reference vessel diameter of 3 to 8 mm.

Who may be able to join

  • Screening Criteria
  • Male or non-pregnant female ≥18 years of age
  • Rutherford Clinical Category 2-4
  • Clinical diagnosis of PAD requiring revascularization, secondary to atherosclerosis affecting a lower limb.
  • Patient is willing to provide informed consent and comply with the required follow up visits Procedural Criteria
  • De novo or nonstented restenotic lesions >90 days from prior angioplasty and/or atherectomy, at least 3 cm from any previously placed stent or vascular surgery site
Show all 10Show fewer
  • >70% diameter stenosis up to 15 cm in total length (with no greater than 3 cm length of contiguous intervening normal artery) in the superficial femoral and/or popliteal artery (between the profunda and tibioperoneal trunk)
  • Reference vessel diameter ≥3mm and ≤ 8mm
  • Successful wire crossing of lesion
  • A patent artery proximal to the index lesion free from significant stenosis (significant stenosis is defined as >50% in iliac or >30% stenosis in common femoral artery) as confirmed by angiography (treatment of target lesion after successful treatment of iliac or common femoral artery lesions is acceptable)

Who cannot join

  • Screening Criteria
  • Pregnant, nursing or planning on becoming pregnant in < 2years
  • Life expectancy of <2 years
  • Known active malignancy
  • History of solid organ transplantation
  • Patient actively participating in another investigational device or drug study
Show all 22Show fewer
  • History of hemorrhagic stroke within 3 months
  • Previous or planned surgical or interventional procedure within 30 days of index procedure
  • Chronic renal insufficiency with eGFR <29
  • Prior bypass surgery, drug-coated balloon or stenting of the target lesion
  • Contra-indication or known hypersensitivity to contrast media or physician prescribed antiplatelet regimen as applicable
  • Systemic fungal infection
  • Anticipated use of IIb/IIIa inhibitor prior to index lesion treatment
  • Acute or sub-acute thrombus, acute vessel occlusion or sudden symptom onset
  • Acute limb ischemia
  • Inability to ambulate (e.g. from prior ipsilateral or contralateral amputation)
  • Patient is receiving steroids already, however locally acting inhaled steroids for asthma treatment do not exclude patients from the trial Procedural Criteria
  • Lesions extending into the trifurcation or above the profunda
  • Heavy eccentric or moderate circumferential calcification at index lesion
  • Lesion length is >15 cm as measured from proximal normal vessel to distal normal vessel, or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured
  • Inadequate distal outflow defined as absence of at least one patent tibial artery (no lesion >50% stenosis) with flow into the foot
  • Use of adjunctive therapies other than angioplasty, atherectomy (mechanical or laser) or bare metal stenting (i.e. scoring/cutting balloon, drug-eluting stent, drug-coated balloon, cryoplasty, etc.)

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Endovascular Technologies (Willis Knighton Medical Center)

    Bossier City, Louisiana, 7111

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • Mission Research Institute

    New Braunfels, Texas, 78130

  • Palestine Regional Medical Center

    Palestine, Texas, 75801

  • Rex Hospital

    Raleigh, North Carolina

Other trials in United States

About this study

This is a prospective, multi-center, observational registry to document the baseline, 24-hour and 30-day inflammatory response and procedural outcomes out to 12 month follow-up after femoropopliteal angioplasty or atherectomy-based revascularization procedures.

Read the detailed description

This is a prospective, multi-center, observational registry to document the baseline, 24-hour and 30-day inflammatory response and procedural outcomes out to 12 month follow-up after femoropopliteal angioplasty or atherectomy-based revascularization procedures.

  1. To observe the femoropopliteal revascularization outcomes post-angioplasty and/or atherectomy and to observe potential correlation between patency outcomes and the levels of MCP-1, C-reactive protein and MMP-9 from baseline to 24 hours and 30 days post-procedure.
  2. To provide a comparator dataset to the investigational DANCE trial, which has the same enrollment criteria as this observational trial but includes the investigational use of a local drug therapy to limit inflammation caused by mechanical revascularization.
Being tested
Balloon Angioplasty, Atherectomy System
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.

  • Balloon AngioplastyDevice

    Device: Balloon Angioplasty Selection is driven by preference of the operator

  • Atherectomy SystemDevice

    Device: Orbital or Directional or Laser Atherectomy Systems Atherectomy selection is driven by preference of the operator

Study groups in NCT02469532
Study groupRoleWhat they receive
AtherectomyUp to 20 atherectomy procedures at up to 5 sites in the United States. Change in inflammatory biomarkers (hs-CRP, MCP-1 and MMP-9) from baseline to 24 hours post-procedure and 30-days post-revascularization procedure. This registry will also observe outcomes (target lesion revascularization rates, 6 and 12 month duplex ultrasound-detected binary restenosis with PSVR>2.4) post-atherectomy revascularization procedures.
Receives: Device: Atherectomy System
AngioplastyUp to 20 angioplasty procedures at up to 5 sites in the United States. Change in inflammatory biomarkers (hs-CRP, MCP-1 and MMP-9) from baseline to 24 hours post-procedure and 30-days post-revascularization procedure. This registry will also observe outcomes (target lesion revascularization rates, 6 and 12 month duplex ultrasound-detected binary restenosis with PSVR>2.4) post-angioplasty revascularization procedures.
Receives: Device: Balloon Angioplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in inflammatory biomarkers

    Change in inflammatory biomarkers (hs-CRP, MCP-1 and MMP-9) from baseline to 24 hours post-procedure and 30-days post-revascularization procedure.

    Measured: Baseline to 24-hours post-procedure and 30-days post-procedure

Secondary outcomes (2)

  1. Target Lesion Revascularization

    This registry will prospectively collect data from patients diagnosed with peripheral arterial disease to observe the restenosis rates in peripheral arteries compared with subjects enrolled in the DANCE trial (Mercator MedSystems TSP0149).

    Measured: 6 and 12 months post-procedure

  2. Comparing biomarker (hs-CRP, MCP-1 and MMP-9) results

    This registry will prospectively collect data from patients diagnosed with peripheral arterial disease to observe the correlation between the levels of MCP-1, C-reactive protein and MMP-9 after angioplasty or atherectomy procedures in peripheral arteries compared with subjects enrolled in the DANCE trial (Mercator MedSystems TSP0149). Objective measurement of biomarkers will be performed by a contract laboratory to avoid bias.

    Measured: Baseline to 24 hours post-procedure and 30-days post-revascularization procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionOct 2017
  4. Study completionJan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
31 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT02469532
Sponsor's protocol ID
CIP0181
Status last verified
Mar 2018
First submitted
14 May 2015
Last updated
8 Mar 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Arterial Disease, run by Mercator MedSystems, Inc. at 6 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 10 inclusion and 22 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: finished, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in inflammatory biomarkers (time frame: Baseline to 24-hours post-procedure and 30-days post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02469532.

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 8 Mar 2018.

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