Clinical trial NCT02469532: DANCE Partner: Inflammatory Biomarker Analysis by Femoropopliteal Revascularization Method and Treatment Outcomes
Official title: DANCE Partner: Inflammatory Biomarker Analysis by Femoropopliteal Revascularization Method and Treatment Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Lead sponsor: Mercator MedSystems, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-11
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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
* \>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)

Exclusion Criteria:

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
* 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.)

Primary outcomes:
measure: Change in inflammatory biomarkers
timeFrame: Baseline to 24-hours post-procedure and 30-days post-procedure
Secondary outcomes:
measure: Target Lesion Revascularization
timeFrame: 6 and 12 months post-procedure
measure: Comparing biomarker (hs-CRP, MCP-1 and MMP-9) results
timeFrame: Baseline to 24 hours post-procedure and 30-days post-revascularization procedure
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Bossier City
country: United States
facility: Endovascular Technologies (Willis Knighton Medical Center)
state: Louisiana
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Raleigh
country: United States
facility: Rex Hospital
state: North Carolina
city: New Braunfels
country: United States
facility: Mission Research Institute
state: Texas
city: Palestine
country: United States
facility: Palestine Regional Medical Center
state: Texas
Study officials:
affiliation: Mission Research, New Braunfels, TX
name: Jason A Yoho, MD
role: PRINCIPAL_INVESTIGATOR
References: