Determining Predictors of Restenosis in Femoropopliteal Lesions

NCT02734095 | Unknown DMC

• 1 other identifier: 52994416.7.0000.5404
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

A prospective, single-center, real-world study on intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (8)

• Plaque Burden Measure

  defined as = (external elastic membrane cross-sectional area - lumen cross-sectional area) ÷ external elastic membrane cross-sectional area

  intraoperative

• Reference Lumen Measure

  defined as = (proximal reference lumen cross-sectional area + distal reference lumen cross-sectional area) x 0.5

  intraoperative

• Reference Diameter Measure

  defined as = (proximal reference diameter + distal reference diameter) x 0.5

  intraoperative

• Stent/reference Diameter Ratio Measure

  defined as = stent diameter ÷ reference diameter

  intraoperative

• Stent Expansion Ratio Measure

  defined as = minimum stent cross-sectional area ÷ reference lumen cross-sectional area

  intraoperative

• Radial Stent Symmetry Index Measure

  defined as = minimum ÷ maximum stent diameter at minimum stent cross-sectional area

  intraoperative

• Axial Stent Symmetry Index Measure

  defined as = minimum ÷ maximum stent cross-sectional area

  intraoperative

• In Stent Restenosis

  12 months (±30 days)

Secondary Outcomes (21)

• Technical success

  intraoperative

• Freedom of reintervention at each follow-up

  Baseline

• Freedom of reintervention at each follow-up

  1 month (± 7 days)

• Freedom of reintervention at each follow-up

  3 months (±30 days)

• Freedom of reintervention at each follow-up

  6 months (±30 days)

Study Arms (1)

Intravascular Ultrasound data

EXPERIMENTAL

Intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.

Device: Ultrasound

Interventions

Ultrasound DEVICE

Intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.

Intravascular Ultrasound data

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stenotic (\>50%) or occlusive atherosclerotic disease of the femoropopliteal arteries;
• Successful lesion passage passed with conventional mechanical guidewires;
• Symptomatic critical limb ischemia (Rutherford 4, 5, 6);
• Life-expectancy of more than 12 months;
• Tha patient must be willing and able to return to the appropriate follow-up times for the duration of the study;
• Te patient must provide written patient informed consent that is approved by the ethics committee.

You may not qualify if:

• Patient refusing treatment;
• The reference segment diameter is not suitable fo available balloon and/or stent design;
• Unsuccessfully treated (\>30% residual stenosis) proximal inflow limiting arterial stenosis;
• Previously implanted stent(s) or percutaneous transluminal angioplasty at the same lesion site;
• The patient has a known allergy to heparin, Aspirin or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies;
• The patent has a history of prior life-threatening contrast media reaction;
• The patient is currently enrolled in another investigational device or drug trial;
• The patient is currently breast-feeding, pregnant or intends to become pregnant;
• The patient is mentally ill or retarded.

Sponsors & Collaborators

• University of Campinas, Brazil: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Related Publications (9)

• DOTTER CT, JUDKINS MP. TRANSLUMINAL TREATMENT OF ARTERIOSCLEROTIC OBSTRUCTION. DESCRIPTION OF A NEW TECHNIC AND A PRELIMINARY REPORT OF ITS APPLICATION. Circulation. 1964 Nov;30:654-70. doi: 10.1161/01.cir.30.5.654. No abstract available.

  PMID: 14226164 BACKGROUND

• Dettinger GB. Defending the military family. Am J Psychiatry. 1979 Jun;136(6):855-6. doi: 10.1176/ajp.136.6.855. No abstract available.

  PMID: 443484 BACKGROUND

• Pentecost MJ, Criqui MH, Dorros G, Goldstone J, Johnston KW, Martin EC, Ring EJ, Spies JB. Guidelines for peripheral percutaneous transluminal angioplasty of the abdominal aorta and lower extremity vessels. A statement for health professionals from a special writing group of the Councils on Cardiovascular Radiology, Arteriosclerosis, Cardio-Thoracic and Vascular Surgery, Clinical Cardiology, and Epidemiology and Prevention, the American Heart Association. Circulation. 1994 Jan;89(1):511-31. doi: 10.1161/01.cir.89.1.511. No abstract available.

  PMID: 8281692 BACKGROUND

• Martin EC, Katzen BT, Benenati JF, Diethrich EB, Dorros G, Graor RA, Horton KM, Iannone LA, Isner JM, Ramee SR, et al. Multicenter trial of the wallstent in the iliac and femoral arteries. J Vasc Interv Radiol. 1995 Nov-Dec;6(6):843-9. doi: 10.1016/s1051-0443(95)71198-8.

  PMID: 8850658 BACKGROUND

• Lammer J, Dake MD, Bleyn J, Katzen BT, Cejna M, Piquet P, Becker GJ, Settlage RA. Peripheral arterial obstruction: prospective study of treatment with a transluminally placed self-expanding stent-graft. International Trial Study Group. Radiology. 2000 Oct;217(1):95-104. doi: 10.1148/radiology.217.1.r00se0595.

  PMID: 11012429 BACKGROUND

• Gray BH, Olin JW. Limitations of percutaneous transluminal angioplasty with stenting for femoropopliteal arterial occlusive disease. Semin Vasc Surg. 1997 Mar;10(1):8-16.

  PMID: 9068071 BACKGROUND

• Ferreira M, Lanziotti L, Monteiro M, Abuhadba G, Capotorto LF, Nolte L, Fearnot N. Superficial femoral artery recanalization with self-expanding nitinol stents: long-term follow-up results. Eur J Vasc Endovasc Surg. 2007 Dec;34(6):702-8. doi: 10.1016/j.ejvs.2007.07.025. Epub 2007 Oct 24.

  PMID: 17920306 BACKGROUND

• Bosiers M, Torsello G, Gissler HM, Ruef J, Muller-Hulsbeck S, Jahnke T, Peeters P, Daenens K, Lammer J, Schroe 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.

  PMID: 19642788 BACKGROUND

• Laird JR, Jain A, Zeller T, Feldman R, Scheinert D, Popma JJ, Armstrong EJ, Jaff MR; Complete SE Investigators. Nitinol stent implantation in the superficial femoral artery and proximal popliteal artery: twelve-month results from the complete SE multicenter trial. J Endovasc Ther. 2014 Apr;21(2):202-12. doi: 10.1583/13-4548R.1.

  PMID: 24754279 BACKGROUND

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Martin A Geiger, MD

  University of Campinas, Brazil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin A Geiger, MD

CONTACT

+55 19 35218936; martinandreasgeiger@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular Surgeon

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 12, 2016
• Study Start: August 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2018
• Last Updated: April 12, 2016

Record last verified: 2016-04