Peripheral Arterial Disease Clinical Trial
Official title:
Evaluation of Short Versus Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization
NCT number | NCT02433587 |
Other study ID # | 08-14-29 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | October 2019 |
Est. completion date | July 2023 |
Verified date | October 2019 |
Source | University Hospitals Cleveland Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of the trial is to evaluate short versus long duration dual antiplatelet therapy in patients undergoing lower extremity endovascular revascularization.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 2023 |
Est. primary completion date | July 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Provide signed informed consent before initiation of any study related procedures 2. Be at least 18 years of age 3. Successful percutaneous lower extremity (iliac and infrainguinal) endovascular revascularization (percutaneous transluminal angioplasty, and /or stent). 4. At least 1 vessel run-off in segment distal to the intervention 5. Rutherford Classification 2-5 that is unresponsive to medical therapy Exclusion Criteria: 1. Acute limb ischemia 2. Procedure includes device deployment that has specific FDA regulations for anticoagulation/anti-platelet medication regimen. 3. Patient undergoing atherectomy procedure 4. Intervention includes deployment of drug eluted stent 5. Critical limb ischemia (Rutherford Classification 6) 6. Thrombocytopenia: Platelet count <50k 7. Liver disease (Childs-Pugh B or C) 8. Existing need for on going clopidogrel therapy 9. Proton Pump Inhibitor Use (If unable to be switched) 10. Need for therapeutic anticoagulation 11. Known hypercoagulable disorder 12. Allergy or contraindication to aspirin or clopidogrel 13. Pregnancy 14. Patients enrolled in another investigational drug or device study within the past 30 days |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals Case Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Cleveland Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major Adverse Cardiovascular Event Rates | Stroke, Myocardial Infarction, Cardiovascular Death | 12 months post-intervention | |
Primary | Major Adverse Limb Event Rates | Severe limb ischemia leading to a reintervention or major vascular amputation | 12 months post-intervention | |
Secondary | Quality of Life Outcome | Assessed by Intermittent Claudication Questionnaire and Short Form-36 Health Survey | 12 Months post-intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06032065 -
Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)
|
Phase 3 | |
Active, not recruiting |
NCT03987061 -
MOTIV Bioresorbable Scaffold in BTK Artery Disease
|
N/A | |
Recruiting |
NCT03506633 -
Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients
|
N/A | |
Active, not recruiting |
NCT03506646 -
Dietary Nitrate Supplementation and Thermoregulation
|
N/A | |
Active, not recruiting |
NCT04677725 -
NEtwork to Control ATherothrombosis (NEAT Registry)
|
||
Recruiting |
NCT05961943 -
RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients
|
N/A | |
Recruiting |
NCT06047002 -
Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
|
||
Completed |
NCT03185052 -
Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach
|
N/A | |
Recruiting |
NCT05992896 -
A Study of Loco-Regional Liposomal Bupivacaine Injection
|
Phase 4 | |
Completed |
NCT04635501 -
AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial
|
N/A | |
Recruiting |
NCT04584632 -
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
|
N/A | |
Withdrawn |
NCT03994185 -
The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease
|
N/A | |
Withdrawn |
NCT03538392 -
Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
|
||
Recruiting |
NCT02915796 -
Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty
|
Phase 1 | |
Active, not recruiting |
NCT02900924 -
Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
|
||
Completed |
NCT02901847 -
To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.
|
N/A | |
Withdrawn |
NCT02126540 -
Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries
|
N/A | |
Not yet recruiting |
NCT02455726 -
Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease
|
N/A | |
Not yet recruiting |
NCT02387450 -
Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication
|
Phase 2/Phase 3 | |
Completed |
NCT02384980 -
Saving Life and Limb: FES for the Elderly With PAD
|
Phase 1 |