Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes

NCT06829914 | Recruiting FDA Device

• 1 other identifier: 021-263
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Common Femoral Artery Stenosis; Calcification; Heart

Outcome Measures

Primary Outcomes (5)

• 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

  1. Acute occlusion of the target lesion 2. Flow-limiting dissection of the target lesion 3. Symptomatic thrombus or embolus in treated limb requiring treatment 4. Unplanned percutaneous/surgical revascularization or amputation above the ankle of the treated limb 5. Access/surgical site complications 1. Bleeding events (specify Bleeding Academic Research Consortium (BARC) type - see Appendix 18.2) 2. Surgical site infection requiring medication or surgery, wound dehiscence, patch/arterial infection, lymphatic leak requiring surgery

  Procedure date through 6 months post-op

Secondary Outcomes (22)

• Mortality

  Procedure date through 1-year post-op

• Rutherford Chronic Limb Ischemia (CLI) Category

  30 days post-op, 3 months post-op, 6 months post-op, 1 year post-op

• Treatment satisfaction and quality of life (PAQ)

  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

Study Arms (2)

Shockwave Catheter

ACTIVE COMPARATOR

Shockwave™ Intravenous Lithotripsy (IVL)+ DCB (Drug Coated Balloon)

Device: Shockwave Catheter

surgical endarterectomy

ACTIVE COMPARATOR

Surgery should be performed with patch angioplasty, with or without profunda femoris endarterectomy.

Procedure: CFA Endarterectomy

Interventions

Shockwave Catheter DEVICE

Shockwave™ IVL + DCB procedure

Shockwave Catheter

CFA Endarterectomy PROCEDURE

Standard CFA endarterectomy

surgical endarterectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CFA atherosclerotic stenosis 60-100%
• Moderate to severe calcification reported on imaging
• Lifestyle-limiting intermittent claudication (IC) or chronic limb-threatening ischemia (CLTI) as described by Rutherford chronic limb ischemia (CLI) category 2-5
• Failing conservative therapy
• Operative candidate for CFE prior to enrollment
• ≥18 years of age

You may not qualify if:

• History of CFE or bypass in affected limb
• Thrombosis of affected CFA
• Aneurysm in the common femoral artery of target limb
• Known target lesion restenosis (re-narrowing of the artery to ≥50% following the alleviation of a previous narrowing within 3 months)
• Any preceding percutaneous cardiovascular intervention within 2 weeks
• Inability to tolerate DAPT
• Known coagulopathy or bleeding diathesis, thrombocytopenia with platelet count \<100,000/µL
• Uncontrolled diabetes (HbA1c ≥10.0%)
• Non-ambulatory
• Extensive tissue loss requiring amputation or salvageable only with complex foot reconstruction or non-traditional transmetatarsal amputations
• MI within 6 weeks (defined as presumed ischemic symptoms (chest pain, ST-segment deviation and troponin higher than 2 times the upper limit of normal))
• Stroke within 3 months (defined as sudden transient or irreversible focal neurological deficit resulting from a cerebrovascular cause)
• Pregnant

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, 75093, United States

RECRUITING

Related Publications (17)

• 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.

  PMID: 18639427 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.

  PMID: 26902450 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.

  PMID: 25702917 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.

  PMID: 32110032 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.

  PMID: 21835313 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.

  PMID: 25101576 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.

  PMID: 29251204 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.

  PMID: 19624078 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.

  PMID: 28797363 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.

  PMID: 30474206 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.

  PMID: 32242768 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.

  PMID: 34380334 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.

  PMID: 35595607 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.

  PMID: 9308598 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.

  PMID: 34167675 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.

  PMID: 37888915 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.

  PMID: 14760329 BACKGROUND

MeSH Terms

Conditions

Calcinosis

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sameh Sayfo, MD

  Baylor Scott & White The Heart Hospital - Plano

  PRINCIPAL INVESTIGATOR

• John Kedora, MD

  Baylor Scott & White The Heart Hospital - Plano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bonnie Ostergren

CONTACT

469-814-4181; Bonnie.Ostergren@BSWHealth.org

Sarah Hale

CONTACT

469-814-4845; Sarah.Hale@BSWHealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized pilot study

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: February 17, 2025
• Study Start: March 7, 2024
• Primary Completion: March 7, 2026
• Study Completion: March 30, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Locations

US (1)