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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment of Femoro-popliteal Atherosclerotic Lesions Using the Ranger Paclitaxel Coated Balloon Catheter. All Comers Registry.

NCT02462005

Atherosclerotic Disease

COMPLETED

Prestige Pilot - Phoenix Atherectomy and Stellarex DCB Clinical Investigation in Infrapopliteal Interventions

NCT03744572

Peripheral Artery Disease (PAD)

COMPLETED

Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)

NCT02923193

Peripheral Arterial Disease

COMPLETED NA

Follow-up Study in French Practice to Evaluate Improvements in Walking and Pain Relief in Patients Treated With Endovascular Treatment of de Novo Lesions of the Femoropopliteal Artery Above the Knee With LUTONIX®035 or RANGER TM Active Ballon

NCT04798352

Drug-coated Balloon Catheter

ACTIVE_NOT_RECRUITING NA

Α Pre CE-Marking Study Using the Rontis Drug Coated Balloon for Treatment of Lesions in Femoropopliteal Arteries

NCT04821388

Peripheral Artery Disease (PAD)

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Arterial Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Atherectomy

Up 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.

Atherectomy System

Intervention Type DEVICE

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

Angioplasty

Up 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.

Balloon Angioplasty

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Balloon Angioplasty

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

Intervention Type DEVICE

Atherectomy System

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No