Cardiovascular Diseases Clinical Trial
— PAVENSTOfficial title:
Randomized Controlled Trial of Paclitaxel Drug-coated Balloons vs. Nitinol Stent for Femoropopliteal Obstructions - The PAVENST Trial
NCT number | NCT02212470 |
Other study ID # | IDPC_3 2014 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | July 2014 |
Est. completion date | October 2019 |
Verified date | June 2021 |
Source | Instituto Dante Pazzanese de Cardiologia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment.
Status | Completed |
Enrollment | 85 |
Est. completion date | October 2019 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients over 18 years with critical lower limb ischemia, - Ruhtherford 3 or higher, - with angiographic documentation of greater than 70% or occlusion in the superficial femoral artery, - with a maximum extension of 10 cm stenosis. - The popliteal artery and at least one leg artery must be patent. Exclusion Criteria: - Pregnancy, - thrombophilia, - coagulation disorders, - presence of active or recent bleeding, - severe allergy to iodinated contrast, - renal or hepatic disease, - acute limb ischemia, - prior surgical bypass or angioplasty (with or without stent) on the target artery, - obstructive disease (stenosis> 50%) of the aortoiliac segment ipsilateral to the target (if the aortoiliac is pre-treated, the patient may be included) |
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto Dante Pazzanese de Cardiologia | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Instituto Dante Pazzanese de Cardiologia | Medtronic |
Brazil,
Abdoli S, Mert M, Lee WM, Ochoa CJ, Katz SG. Network meta-analysis of drug-coated balloon angioplasty versus primary nitinol stenting for femoropopliteal atherosclerotic disease. J Vasc Surg. 2021 May;73(5):1802-1810.e4. doi: 10.1016/j.jvs.2020.10.075. Ep — View Citation
Bosiers M, Torsello G, Gissler HM, Ruef J, Müller-Hülsbeck S, Jahnke T, Peeters P, Daenens K, Lammer J, Schroë H, Mathias K, Koppensteiner R, Vermassen F, Scheinert D. Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study. J Endovasc Ther. 2009 Jun;16(3):261-9. doi: 10.1583/08-2676.1. — View Citation
Dake MD, Scheinert D, Tepe G, Tessarek J, Fanelli F, Bosiers M, Ruhlmann C, Kavteladze Z, Lottes AE, Ragheb AO, Zeller T; Zilver PTX Single-Arm Study Investigators. Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: twelve-month safety and effectiveness results from the Zilver PTX single-arm clinical study. J Endovasc Ther. 2011 Oct;18(5):613-23. doi: 10.1583/11-3560.1. — View Citation
Dick P, Wallner H, Sabeti S, Loewe C, Mlekusch W, Lammer J, Koppensteiner R, Minar E, Schillinger M. Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions. Catheter Cardiovasc Interv. 2009 Dec 1;74(7):1090-5. doi: 10.1002/ccd.22128. — View Citation
Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Oliva V, Tielbeek A, Anderson J, Wiesinger B, Tepe G, Lansky A, Jaff MR, Mudde C, Tielemans H, Beregi JP. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther. 2006 Dec;13(6):701-10. — View Citation
Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Tielbeek A, Anderson J, Wiesinger B, Tepe G, Lansky A, Mudde C, Tielemans H, Bérégi JP. Sirolimus-eluting versus bare nitinol stent for obstructive superficial femoral artery disease: the SIROCCO II trial. J Vasc Interv Radiol. 2005 Mar;16(3):331-8. — View Citation
Freyhardt P, Zeller T, Kröncke TJ, Schwarzwaelder U, Schreiter NF, Stiepani H, Sixt S, Rastan A, Werk M. Plasma levels following application of paclitaxel-coated balloon catheters in patients with stenotic or occluded femoropopliteal arteries. Rofo. 2011 May;183(5):448-55. doi: 10.1055/s-0029-1246028. Epub 2011 Jan 27. — View Citation
Geiger MA, Guillaumon AT. Primary stenting for femoropopliteal peripheral arterial disease: analysis up to 24 months. J Vasc Bras. 2019 Jan 30;18:e20160104. doi: 10.1590/1677-5449.010416. eCollection 2019. — View Citation
Iida O, Soga Y, Hirano K, Suzuki K, Yokoi H, Nobuyoshi M, Muramatsu T, Inoue N, Nanto S, Uematsu M. Long-term outcomes and risk stratification of patency following nitinol stenting in the femoropopliteal segment: retrospective multicenter analysis. J Endo — View Citation
Kasapis C, Henke PK, Chetcuti SJ, Koenig GC, Rectenwald JE, Krishnamurthy VN, Grossman PM, Gurm HS. Routine stent implantation vs. percutaneous transluminal angioplasty in femoropopliteal artery disease: a meta-analysis of randomized controlled trials. Eur Heart J. 2009 Jan;30(1):44-55. doi: 10.1093/eurheartj/ehn514. Epub 2008 Nov 21. — View Citation
Kawamura Y, Ishii H, Aoyama T, Tanaka M, Takahashi H, Kumada Y, Toriyama T, Murohara T. Nitinol stenting improves primary patency of the superficial femoral artery after percutaneous transluminal angioplasty in hemodialysis patients: a propensity-matched analysis. J Vasc Surg. 2009 Nov;50(5):1057-62. doi: 10.1016/j.jvs.2009.07.017. Epub 2009 Sep 26. — View Citation
Krankenberg H, Schlüter M, Steinkamp HJ, Bürgelin K, Scheinert D, Schulte KL, Minar E, Peeters P, Bosiers M, Tepe G, Reimers B, Mahler F, Tübler T, Zeller T. Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST). Circulation. 2007 Jul 17;116(3):285-92. Epub 2007 Jun 25. — View Citation
Krishnan P, Faries P, Niazi K, Jain A, Sachar R, Bachinsky WB, Cardenas J, Werner M, Brodmann M, Mustapha JA, Mena-Hurtado C, Jaff MR, Holden AH, Lyden SP. Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease: Twelve-Month Outcomes From the Randomized ILLUMENATE Pivotal and Pharmacokinetic Studies. Circulation. 2017 Sep 19;136(12):1102-1113. doi: 10.1161/CIRCULATIONAHA.117.028893. Epub 2017 Jul 20. — View Citation
Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Cao AY, Jaff MR; RESILIENT Investigators. Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year follow-up from the RESILIENT randomized trial. J Endovasc Ther. 2012 Feb;19(1):1-9. doi: 10.1583/11-3627.1. — View Citation
Lammer J, Bosiers M, Zeller T, Schillinger M, Boone E, Zaugg MJ, Verta P, Peng L, Gao X, Schwartz LB. First clinical trial of nitinol self-expanding everolimus-eluting stent implantation for peripheral arterial occlusive disease. J Vasc Surg. 2011 Aug;54(2):394-401. doi: 10.1016/j.jvs.2011.01.047. Epub 2011 Jun 12. — View Citation
Leiner T, Kessels AG, Nelemans PJ, Vasbinder GB, de Haan MW, Kitslaar PE, Ho KY, Tordoir JH, van Engelshoven JM. Peripheral arterial disease: comparison of color duplex US and contrast-enhanced MR angiography for diagnosis. Radiology. 2005 May;235(2):699-708. — View Citation
Micari A, Cioppa A, Vadalà G, Castriota F, Liso A, Marchese A, Grattoni C, Pantaleo P, Cremonesi A, Rubino P, Biamino G. Clinical evaluation of a paclitaxel-eluting balloon for treatment of femoropopliteal arterial disease: 12-month results from a multicenter Italian registry. JACC Cardiovasc Interv. 2012 Mar;5(3):331-8. doi: 10.1016/j.jcin.2011.11.010. — View Citation
Mwipatayi BP, Hockings A, Hofmann M, Garbowski M, Sieunarine K. Balloon angioplasty compared with stenting for treatment of femoropopliteal occlusive disease: a meta-analysis. J Vasc Surg. 2008 Feb;47(2):461-9. Epub 2007 Oct 22. Review. — View Citation
Nguyen BN, Conrad MF, Guest JM, Hackney L, Patel VI, Kwolek CJ, Cambria RP. Late outcomes of balloon angioplasty and angioplasty with selective stenting for superficial femoral-popliteal disease are equivalent. J Vasc Surg. 2011 Oct;54(4):1051-1057.e1. doi: 10.1016/j.jvs.2011.03.283. Epub 2011 Jun 2. — View Citation
Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G; VIVA Physicians, Inc. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007 May 1;69(6):910-9. — View Citation
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. Erratum in: J Vasc Surg 2001 Apr;33(4):805. — View Citation
Schillinger M, Sabeti S, Dick P, Amighi J, Mlekusch W, Schlager O, Loewe C, Cejna M, Lammer J, Minar E. Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting. Circulation. 2007 May 29;115(21):2745-9. Epub 2007 May 14. — View Citation
Schneider PA, Laird JR, Tepe G, Brodmann M, Zeller T, Scheinert D, Metzger C, Micari A, Sachar R, Jaff MR, Wang H, Hasenbank MS, Krishnan P; IN.PACT SFA Trial Investigators. Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries: Long-Term Results of the IN.PACT SFA Randomized Trial. Circ Cardiovasc Interv. 2018 Jan;11(1):e005891. doi: 10.1161/CIRCINTERVENTIONS.117.005891. — View Citation
Schroeder H, Werner M, Meyer DR, Reimer P, Krüger K, Jaff MR, Brodmann M; ILLUMENATE EU RCT Investigators. Low-Dose Paclitaxel-Coated Versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease: One-Year Results of the ILLUMENATE European Randomized Clinical Trial (Randomized Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon). Circulation. 2017 Jun 6;135(23):2227-2236. doi: 10.1161/CIRCULATIONAHA.116.026493. Epub 2017 Apr 19. — View Citation
Serruys PW, Kutryk MJ, Ong AT. Coronary-artery stents. N Engl J Med. 2006 Feb 2;354(5):483-95. Review. — View Citation
Tomoi Y, Soga Y, Takahara M, Fujihara M, Iida O, Kawasaki D, Ando K. Spot stenting versus full coverage stenting after endovascular therapy for femoropopliteal artery lesions. J Vasc Surg. 2019 Oct;70(4):1166-1176. doi: 10.1016/j.jvs.2018.12.044. Epub 201 — View Citation
Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8. Erratum in: Circulation. 2008 Oct 14;118(16):e670. — View Citation
* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary patency | Evaluations will be conducted after 3, 6 and 12 months of the procedure. The ultrasonographic evaluation of the degree of stenosis will use the Systolic Velocity Index (division of the velocity of flow at the point of greatest stenosis by the velocity of flow in normal prior segment). Rates higher than 2.4 indicate stenosis greater than 50% | 12 months | |
Secondary | Rutherford classification | Change in classification from Rutherford evaluated in 3, 6 and 12 months. | 12 months | |
Secondary | Ankle braquial Index | Change in the Ankle braquial Index evaluated in 3, 6 and 12 months | 12 months | |
Secondary | Target Lesion Revascularization | Target Lesion Revascularization rate evaluated in 3, 6 and 12 months | 12 months | |
Secondary | Stent fracture | Stent fracture rate evaluated in 3, 6 and 12 months | 12 months | |
Secondary | Amputation | Major amputation defined as amputation that requires prosthesis | 12 months | |
Secondary | Acute myocardial infarct | Acute myocardial infarct rate evaluated in 3, 6 and 12 months | 12 months | |
Secondary | Death | Death rate evaluated in 3, 6 and 12 months | 12 months |
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