Femoral Artery Occlusion Clinical Trial
— CONFIRMOfficial title:
A Prospective, Multicenter, Single Arm, Post-Approval Study of the Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females
Verified date | April 2020 |
Source | C. R. Bard |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The post approval study will enroll US female patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects are treated per Instructions For Use (IFU) with the Lutonix® Catheter. Subjects will have a Duplex Ultrasound (DUS) and clinical follow-up through two (2) years.
Status | Terminated |
Enrollment | 4 |
Est. completion date | February 18, 2019 |
Est. primary completion date | February 18, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Clinical Criteria 1. Non-pregnant female =18 years of age; 2. Rutherford Clinical Category 2-4; 3. Patient is willing to provide informed consent, is geographically stable, comply with the required follow up visits and testing schedule; Angiographic Criteria 4. De novo or restenotic lesion(s) in native superficial femoral or popliteal arteries; 5. Lesion =70% stenosis by visual estimate; 6. Target reference vessel diameter of 4-7 mm; 7. A patent inflow artery free from significant lesion (=50% stenosis) as confirmed by angiography; (Treatment of target lesion acceptable after successful treatment of inflow artery lesions. Successful inflow artery treatment is defined as attainment of residual diameter stenosis =30% without death or major vascular complication.) 8. At least one patent native outflow artery to the ankle, free from significant (=50%) stenosis as confirmed by angiography after successful vessel preparation; 9. Successful antegrade wire crossing and vessel preparation (may include pre-dilatation) of the target lesion. Successful vessel preparation is defined by residual stenosis =30% without any major vascular complications; 10. No other prior vascular interventions within 2 weeks before and/or planned 30 days after the protocol treatment except for remote common femoral patch angioplasty separated by at least 2 cm from the lesion(s). Exclusion Criteria 1. Life expectancy of <2 years; 2. Subject is currently participating in an investigational drug or device study, or previously enrolled in this study. Enrollment in another investigational drug or device study during the follow up period is not allowed; 3. History of stroke within 3 months; 4. History of myocardial infarction (MI), thrombolysis or angina within 2 weeks of index procedure; 5. Renal failure or chronic kidney disease with serum creatinine =2.5 mg/L within 30 days of index procedure or treated with dialysis; 6. Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel. |
Country | Name | City | State |
---|---|---|---|
United States | Midwest Cardiovascular Research Foundation | Davenport | Iowa |
United States | St. Vincent Medical Group | Indianapolis | Indiana |
United States | Wellmont CVA Heart Institute | Kingsport | Tennessee |
United States | Vascular Access Solutions | Orangeburg | South Carolina |
Lead Sponsor | Collaborator |
---|---|
C. R. Bard |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Freedom From the Following: All-cause Peri-operative Death at 30 Days, Index Limb Amputation Within 1 Year, Index Limb Re-intervention Within 1 Year, and Index-limb-Related Death Within 1 Year Post Index Procedure | Index limb amputation includes above or below the ankle amputations. | 12 months post index procedure | |
Primary | Effectiveness: Number of Participants With Primary Patency of the Target Lesion at 12 Month Post Index Procedure. | Primary patency is defined as freedom from target lesion restenosis (TLR) and from binary restenosis. Binary restenosis is adjudicated by the independent Core Laboratory based on Peak Systolic Velocity Ratio (PSVR) = 2.5 and / or abnormal waveforms, or based on angiographic = 50% diameter stenosis. | 12 months post index procedure | |
Secondary | Number of Participants With Freedom From All-cause Perioperative (= 30 Day) Death and Freedom From the Following: Index Limb Amputation, Index Limb Re-intervention, and Index-Limb-Related Death. | 30 days post index procedure | ||
Secondary | Number of Major Vascular Complications at 30 Days Post Index Procedure | 30 days | ||
Secondary | Number of Deaths (All Causes) at 30 Days Post Index Procedure | 30 days post index procedure | ||
Secondary | Number of Participants With Clinically Driven Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Month Post Index Procedure | 1, 6, 12 and 24 months post index procedure | ||
Secondary | Number of Participants With Target Vessel Revascularization (TVR) at 1, 6, 12, and 24 Months Post Index Porcedure | 1, 6, 12 and 24 months post index procedure | ||
Secondary | Number of Participants With Reintervention for Treatment of Thrombosis of the Target Vessel or Embolization to Its Distal Vasculature at 1, 6, 12, and 24 Months Post Index Procedure | 1, 6, 12 and 24 months post index procedure | ||
Secondary | Number of Participants With Unanticipated and Anticipated Device Related Serious Adverse Events at 1, 6, 12, and 24 Months Post Index Procedure | 1, 6, 12 and 24 months post index procedure | ||
Secondary | Number of Participants With Amputation (Above the Ankle)-Free Survival (AFS) at 1, 6, 12, and 24 Months Post Index Procedure. | 1, 6, 12 and 24 months | ||
Secondary | Change in Rutherford Classification Scores at 1, 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 1, 6, 12 and 24 months post index procedure | ||
Secondary | Number of Participants With Sustained Clinical Benefit at 1, 6, 12, and 24 Months Post Index Procedure | 1, 6, 12 and 24 months post index procedure | ||
Secondary | Change of Resting Ankle Brachial Index (ABI) Scores at 1, 6, 12, and 24 Months Post Index Procedure Compared to Baseline | 1, 6, 12 and 24 months post index procedure |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01947478 -
MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery
|
N/A | |
Recruiting |
NCT03687983 -
Safety and Efficacy Study of GoldenFlow Peripheral Stent System
|
N/A | |
Completed |
NCT02720003 -
A Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries
|
N/A | |
Completed |
NCT02063672 -
Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
|
N/A | |
Completed |
NCT01816412 -
LEVANT Japan Clinical Trial
|
Phase 2 | |
Completed |
NCT01566461 -
IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)
|
N/A | |
Completed |
NCT01412541 -
Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries
|
N/A | |
Recruiting |
NCT03683459 -
Safety and Efficacy Study of FemFlow Drug-Eluting Peripheral Balloon Catheter
|
N/A | |
Recruiting |
NCT03142347 -
Remote Endarterectomy vs Remote Endarterectomy + Drug Coated Balloon (DCB) Angioplasty in Patients With the Femoral Artery Occlusive Disease
|
N/A | |
Terminated |
NCT00810134 -
Bypass or Thurpass for Superficial Femoral Artery Occlusion? Scandinavian Thurpass Study
|
N/A | |
Active, not recruiting |
NCT05734157 -
CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery
|
N/A | |
Completed |
NCT02013271 -
Lutonix® DCB for Treatment of Long Lesions in Femoropopliteal Arteries
|
||
Completed |
NCT04343196 -
Digital Variance Angiography in Diagnostic Angiographies for Effective Radiation Dose Reduction
|
N/A | |
Completed |
NCT03844724 -
Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion
|
N/A |