This trial is active, not recruiting.

Condition peripheral arterial diseases
Treatment dexamethasone sodium phosphate injection, usp
Phase phase 4
Sponsor Mercator MedSystems, Inc.
Start date November 2013
End date December 2016
Trial size 285 participants
Trial identifier NCT01983449, 1142183, TSP0149


To assess the safety and effectiveness of adventitial deposition of the Study Drug in reducing inflammation and restenosis in patients with clinical evidence of claudication or critical limb ischemia and an angiographically significant lesion in the superficial femoral and/or popliteal arteries.

Study Drug and Dose: Dexamethasone Sodium Phosphate Injection, USP, 4 mg/ml, with dilute contrast (17%) administered to the adventitia in a dose of 1.6 mg per cm of desired vessel treatment length.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
In patients receiving either angioplasty or atherectomy-based revascularization (pre-stratified to each by 50% of the total study), dexamethasone will be delivered to the adventitia following revascularization.
dexamethasone sodium phosphate injection, usp
Adventitial infusion of dexamethasone after angioplasty or atherectomy-based revascularization of the superficial femoral or popliteal artery.

Primary Outcomes

time frame: 30 days
Duplex ultrasound index lesion binary restenosis
time frame: 6 months
Duplex ultrasound index lesion binary restenosis
time frame: 12 months

Secondary Outcomes

Long term safety
time frame: 30 days to 6 months
Duplex ultrasound index lesion flow limiting restenosis
time frame: 6 and 12 months
Change in inflammatory biomarkers
time frame: Baseline and 24 hours
Vascular patency
time frame: 6, 12, 18 and 24 months
Clinical outcome measures
time frame: 1, 6, 12, 18 and 24 months
Infusion Technical Success
time frame: Intraprocedural
Procedural Success
time frame: Intraprocedural
Healthcare Economics
time frame: 30 days

Eligibility Criteria

All participants at least 18 years old.

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, testing schedule, and medication regimen - 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 < 2 years - 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, stenting of the target lesion - Inability to take required study medications - Contra-indication or known hypersensitivity to dexamethasone sodium phosphate, contrast media, or Physician prescribed antiplatelet regimen as indicated - 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 - Prior participation of the index limb in the current study (contralateral treatment is allowed) - 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, which in the judgment of the investigator would prevent penetration of the Micro-Infusion Catheter needle through the vessel wall - 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.)

Additional Information

Official title Delivery of Dexamethasone to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization
Principal investigator Mahmood Razavi, MD
Description This trial will examine the ability for adventitial dexamethasone to safely delay restenosis in patients at least 18 years of age, who have peripheral atherosclerotic lesions involving the superficial femoral and/or popliteal arteries. These patients have no current therapeutic alternatives beyond the procedure used to open, or revascularize, their superficial femoral and/or popliteal arteries. Metal stents have the potential to fracture when implanted in this artery segment due to continual flexion and bending of the knee. It is desirable to improve the patency of this artery after percutaneous transluminal angioplasty (PTA) and/or atherectomy-based revascularization.
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Mercator MedSystems, Inc..