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The investigators hypothesize that Shockwave with DCB is non-inferior to surgical endarterectomy for common femoral artery (CFA) stenosis with regard to primary efficacy and safety endpoints. The study will challenge the current guideline that recommends common femoral endarterectomy (CFE) as the primary treatment for symptomatic CFA stenosis.
This is a pilot, prospective, randomized clinical trial. This trial compares patients with severe symptomatic moderate to severe calcified CFA stenosis undergoing traditional gold standard CFA endarterectomy to innovative technique of endovascular treatment using Shockwaveâ„¢ Intra vascular Lithotripsy (IVL) using M5+ balloon with Drug coated balloon to achieve removal and debulking of plaque and achieve luminal gain. Patients who meet inclusion criteria will be informed and consented by a clinical coordinator if they wish to participate in the trial. If participants are candidates for surgery, they will then be randomized into one of two cohorts, receiving either Shockwaveâ„¢ IVL + DCB (drug-coated balloon) procedure or a standard surgical endarterectomy. The study compares the 1-year efficacy and 6-month safety outcomes post-procedure for patients with severe, symptomatic CFA stenosis receiving Shockwaveâ„¢ IVL with DCB versus surgical endarterectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shockwave Catheter | Active Comparator | Shockwaveâ„¢ Intravenous Lithotripsy (IVL)+ DCB (Drug Coated Balloon) |
|
| surgical endarterectomy | Active Comparator | Surgery should be performed with patch angioplasty, with or without profunda femoris endarterectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shockwave Catheter | Device | Shockwaveâ„¢ IVL + DCB procedure |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically driven target lesion revascularization (cdTLR (symptom-driven repeat revascularization of the index lesion)) | Procedure date through 1-year post-op | |
| Restenosis to ≥ 50% of the target lesion on angiography or follow-up ultrasound | Procedure date through 1-year post-op | |
| Freedom from perioperative death | Procedure date through 30 days post-op | |
| Freedom from major adverse cardiovascular events (MACE (stroke, myocardial infarction (MI), cardiovascular death)) | Procedure date through 30 days post-op | |
| Freedom from major adverse events |
| Procedure date through 6 months post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Procedure date through 1-year post-op | |
| Rutherford Chronic Limb Ischemia (CLI) Category | https://www.ncbi.nlm.nih.gov/books/NBK553864/table/ch20.Tab2/# Stage 0 - Asymptomatic. Stage 1 - Mild claudication - Completes treadmill exercise; Ankle Pressure (AP) after exercise >50 mmHg but at least 20 mmHg lower than resting value. Stage 2 - Moderate claudication - Between categories 1 and 3. Stage 3 - Severe claudication - Cannot complete standard treadmill exercise and AP after exercise <50 mm Hg. Stage 4 - Ischemic rest pain - Resting AP <40 mm Hg, flat or barely pulsatile ankle or metatarsal pulse volume recording (PVR); Toe Pressure (TP) < 30 mm Hg. Stage 5 - Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia- Resting AP < 60 mm Hg, ankle or metatarsal PVR flat or barely pulsatile; TP < 40 mm Hg Stage 6 - Major tissue loss-extending above TM level, functional foot no longer salvageable - Same as category 5 |
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Inclusion Criteria:
A patient will be eligible for inclusion in this study if he or she meets all of the following criteria (confirmed by core lab):
Exclusion Criteria:
A patient will be ineligible for inclusion in this study if he or she meets any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sameh Sayfo, MD | Baylor Scott & White The Heart Hospital - Plano | Principal Investigator |
| John Kedora, MD | Baylor Scott & White The Heart Hospital - Plano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott & White The Heart Hospital - Plano | Plano | Texas | 75093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18639427 | Background | Kang JL, Patel VI, Conrad MF, Lamuraglia GM, Chung TK, Cambria RP. Common femoral artery occlusive disease: contemporary results following surgical endarterectomy. J Vasc Surg. 2008 Oct;48(4):872-7. doi: 10.1016/j.jvs.2008.05.025. Epub 2008 Jul 17. | |
| 26902450 | Background | Kuma S, Tanaka K, Ohmine T, Morisaki K, Kodama A, Guntani A, Ishida M, Okazaki J, Mii S. Clinical Outcome of Surgical Endarterectomy for Common Femoral Artery Occlusive Disease. Circ J. 2016;80(4):964-9. doi: 10.1253/circj.CJ-15-1177. Epub 2016 Feb 19. |
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Prospective, randomized pilot study
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| CFA Endarterectomy |
| Procedure |
Standard CFA endarterectomy |
|
| 30 days post-op, 3 months post-op, 6 months post-op, 1 year post-op |
| Treatment satisfaction and quality of life (PAQ) | Measured by the Peripheral Artery Questionnaire (PAQ), a 20-question questionnaire measuring peripheral vascular disease affect on quality of life. Questionnaires may be completed in-person or via phone call conducted by the study coordinator. | Pre-op, 30 days post-op, 6 months post-op, 1 year post-op |
| Intraoperative blood transfusion > 4 minutes | Intra-op |
| Procedural duration (minutes) | Intra-op |
| Length of stay (days) | Procedure date through 1 year post-op |
| Postoperative anemia requiring blood transfusion | Procedure date through 30 days post-op |
| Readmissions | 30 days post-op, 30 days post-discharge |
| Return to the operating room / angiography suite | 30 days post-op |
| Access/surgical site complications |
| 30 days post-op, 6 months post-op |
| Pneumonia (number of cases) | Patients must meet criteria from both sections: Radiology: One definitive chest radiological exam (x-ray or CT) with at least one of the following:
Patients with underlying pulmonary or cardiac disease require two serial chest radiological exams (x-ray or CT) taken no less than 12 hours apart, but no more than 7 days apart. Signs/Symptoms/Laboratory: at least one of the following:
| Procedure date through 30 days post-op |
| Prolonged intubation | Intubation greater than 48 hours postoperatively | Procedure date through 30 days post-op |
| Urinary tract infection | Must meet one of the following TWO criteria within 30 days of the operation:
AND urine culture of >105 colonies/mL urine with no more than two species of organisms OR two of the following:
AND any of the following:
| Procedure date through 30 days post-op |
| Sepsis | The disorder spectrum spans from relatively mild physiologic abnormalities to septic shock. The most significant level is reported using the following criteria: SIRS (Systemic Inflammatory Response Syndrome), clinically recognized by the presence of two or more of the following in the same time frame: Temp >38 degrees C or 90 bpm RR >20 breaths/min or PaCO2 12,000 cell/mm3, 10% immature (band) forms anion gap acidosis. Report if the patient has clinical signs and symptoms of SIRS listed above and meets either A or B: A. One of the following:
B. Suspected pre-operative infection or bowel infarction leading to the surgical procedure. Procedural findings must confirm this suspected diagnosis with one or more of the following:
| Procedure date through 30 days post-op |
| Septic shock | Report this variable if the patient has sepsis AND documented organ and/or circulatory dysfunction. Examples of organ dysfunction include: oliguria, acute alteration in mental status, acute respiratory distress. Examples of circulatory dysfunction include: hypotension, requirement of inotropic or vasopressor agents. The presence of pneumatosis along with the presence of SIRS is assigned. | Procedure date through 30 days post-op |
| Graft failure | Mechanical failure of an extracardiac graft or prosthesis including myocutaneous flaps and skin grafts requiring return to the operating room, interventional radiology or a balloon angioplasty within 30 days of the operation. | Procedure date through 30 days post-op |
| Cardiac arrest | The absence of cardiac rhythm or presence of chaotic cardiac rhythm, intraoperatively or postoperatively, which results in a cardiac arrest requiring the initiation of CPR, which includes chest compressions. Patients are included who are in a pulseless VT or Vfib in in which defibrillation is performed and PEA arrests requiring chest compressions. Patients with automated implantable cardioverter defibrillator (AICD) that fire but the patient has no loss of consciousness should be excluded. | Procedure date through 30 days post-op |
| Myocardial infarction | Documentation of one or more of the following changes indicative of acute MI:
| Procedure date through 30 days post-op |
| Acute kidney injury | In a patient who did not require dialysis preoperatively, worsening of renal dysfunction postoperatively requiring hemodialysis, peritoneal dialysis, hemofiltration, hemodiafiltration, or ultrafiltration | Procedure date through 30 days post-op |
| Dialysis | Initiation of hemodialysis, peritoneal dialysis, hemofiltration, hemodiafiltration or ultrafiltration in a patient not previously on said therapy preoperatively | Procedure date through 30 days post-op |
| Deep vein thrombosis | New diagnosis of blood clot or thrombus within the venous system (superficial or deep) which may be coupled with inflammation and requires treatment. Must be noted within 30 days after the principal operative procedure AND one of the following A or B below: A.New Diagnosis of a [new] venous thrombosis (superficial or deep), confirmed by a duplex, venogram, CT scan, or any other definitive imaging modality (including direct pathology examination such as autopsy) AND the patient must be treated with anticoagulation therapy and/or placement of a vena cava filter or clipping of the vena cava, or the record indicates that treatment was warranted but there was no additional appropriate treatment option available. B. As per (A) above, but the patient or decisionmaker has refused treatment. There must be documentation in the medical record of the [patient's] refusal of treatment. | Procedure date through 30 days post-op |
| Pulmonary embolism | Lodging of a blood clot in the pulmonary artery with subsequent obstruction of blood supply to the lung parenchyma. The blood clots usually originate from the deep leg veins or pelvic venous system. Since there are not always preoperative studies proving that a clot or thrombus was not present preoperatively, the technical specification of the variable requires only a "new diagnosis"- in other words the clot or thrombus was not previously known. A pulmonary embolism must be noted within 30 days after the principal operative procedure AND the following criteria, A AND B below: A. New diagnosis of a new blood clot in a pulmonary artery AND B. The patient has a V-Q scan interpreted as high probability of pulmonary embolism or a positive CT exam, TEE, pulmonary arteriogram, CT angiogram, or any other definitive imaging modality (including direct pathology examination such as autopsy | Procedure date through 30 days post-op |
| 25702917 | Background | Nguyen BN, Amdur RL, Abugideiri M, Rahbar R, Neville RF, Sidawy AN. Postoperative complications after common femoral endarterectomy. J Vasc Surg. 2015 Jun;61(6):1489-94.e1. doi: 10.1016/j.jvs.2015.01.024. Epub 2015 Feb 19. |
| 32110032 | Background | Shammas NW, Abi Doumet A, Karia R, Khalafallah R. An Overview of the Treatment of Symptomatic Common Femoral Artery Lesions with a Focus on Endovascular Therapy. Vasc Health Risk Manag. 2020 Feb 20;16:67-73. doi: 10.2147/VHRM.S242291. eCollection 2020. |
| 21835313 | Background | Bonvini RF, Rastan A, Sixt S, Noory E, Schwarz T, Frank U, Roffi M, Dorsaz PA, Schwarzwalder U, Burgelin K, Macharzina R, Zeller T. Endovascular treatment of common femoral artery disease: medium-term outcomes of 360 consecutive procedures. J Am Coll Cardiol. 2011 Aug 16;58(8):792-8. doi: 10.1016/j.jacc.2011.01.070. |
| 25101576 | Background | Linni K, Ugurluoglu A, Hitzl W, Aspalter M, Holzenbein T. Bioabsorbable stent implantation vs. common femoral artery endarterectomy: early results of a randomized trial. J Endovasc Ther. 2014 Aug;21(4):493-502. doi: 10.1583/14-4699R.1. |
| 29251204 | Background | Stavroulakis K, Schwindt A, Torsello G, Beropoulis E, Stachmann A, Hericks C, Bollenberg L, Bisdas T. Directional Atherectomy With Antirestenotic Therapy vs Drug-Coated Balloon Angioplasty Alone for Common Femoral Artery Atherosclerotic Disease. J Endovasc Ther. 2018 Feb;25(1):92-99. doi: 10.1177/1526602817748319. Epub 2017 Dec 18. |
| 19624078 | Background | Garcia LA, Lyden SP. Atherectomy for infrainguinal peripheral artery disease. J Endovasc Ther. 2009 Apr;16(2 Suppl 2):II105-15. doi: 10.1583/08-2656.1. |
| 28797363 | Background | Brodmann M, Werner M, Brinton TJ, Illindala U, Lansky A, Jaff MR, Holden A. Safety and Performance of Lithoplasty for Treatment of Calcified Peripheral Artery Lesions. J Am Coll Cardiol. 2017 Aug 15;70(7):908-910. doi: 10.1016/j.jacc.2017.06.022. No abstract available. |
| 30474206 | Background | Brodmann M, Werner M, Holden A, Tepe G, Scheinert D, Schwindt A, Wolf F, Jaff M, Lansky A, Zeller T. Primary outcomes and mechanism of action of intravascular lithotripsy in calcified, femoropopliteal lesions: Results of Disrupt PAD II. Catheter Cardiovasc Interv. 2019 Feb 1;93(2):335-342. doi: 10.1002/ccd.27943. Epub 2018 Nov 25. |
| 32242768 | Background | Adams G, Shammas N, Mangalmurti S, Bernardo NL, Miller WE, Soukas PA, Parikh SA, Armstrong EJ, Tepe G, Lansky A, Gray WA. Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study. J Endovasc Ther. 2020 Jun;27(3):473-480. doi: 10.1177/1526602820914598. Epub 2020 Apr 3. |
| 34380334 | Background | Adams G, Soukas PA, Mehrle A, Bertolet B, Armstrong EJ. Intravascular Lithotripsy for Treatment of Calcified Infrapopliteal Lesions: Results from the Disrupt PAD III Observational Study. J Endovasc Ther. 2022 Feb;29(1):76-83. doi: 10.1177/15266028211032953. Epub 2021 Aug 12. |
| 35595607 | Background | Baig M, Kwok M, Aldairi A, Imran HM, Khan MS, Moustafa A, Hyder ON, Saad M, Aronow HD, Soukas PA. Endovascular Intravascular Lithotripsy in the Treatment of Calcific Common Femoral Artery Disease: A Case Series With an 18-Month Follow-Up. Cardiovasc Revasc Med. 2022 Oct;43:80-84. doi: 10.1016/j.carrev.2022.05.003. Epub 2022 May 7. |
| 9308598 | Background | Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, Jones DN. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997 Sep;26(3):517-38. doi: 10.1016/s0741-5214(97)70045-4. |
| 34167675 | Background | Tepe G, Brodmann M, Werner M, Bachinsky W, Holden A, Zeller T, Mangalmurti S, Nolte-Ernsting C, Bertolet B, Scheinert D, Gray WA; Disrupt PAD III Investigators. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1352-1361. doi: 10.1016/j.jcin.2021.04.010. |
| 37888915 | Background | Varcoe RL, DeRubertis BG, Kolluri R, Krishnan P, Metzger DC, Bonaca MP, Shishehbor MH, Holden AH, Bajakian DR, Garcia LA, Kum SWC, Rundback J, Armstrong E, Lee JK, Khatib Y, Weinberg I, Garcia-Garcia HM, Ruster K, Teraphongphom NT, Zheng Y, Wang J, Jones-McMeans JM, Parikh SA; LIFE-BTK Investigators. Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease. N Engl J Med. 2024 Jan 4;390(1):9-19. doi: 10.1056/NEJMoa2305637. Epub 2023 Oct 25. |
| 14760329 | Background | Spertus J, Jones P, Poler S, Rocha-Singh K. The peripheral artery questionnaire: a new disease-specific health status measure for patients with peripheral arterial disease. Am Heart J. 2004 Feb;147(2):301-8. doi: 10.1016/j.ahj.2003.08.001. |
| ID | Term |
|---|---|
| D002114 | Calcinosis |
| ID | Term |
|---|---|
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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