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Single Ambulatory Phlebectomy versus endovenous Thermal Ablation with concomitant ambulatory Phlebectomies


- candidate number19527
- NTR NumberNTR4821
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-sep-2014
- Secondary IDsNL49701.078.14 METC
- Public TitleSingle Ambulatory Phlebectomy versus endovenous Thermal Ablation with concomitant ambulatory Phlebectomies
- Scientific TitleSingle Ambulatory Phlebectomy versus endovenous Thermal Ablation with concomitant ambulatory Phlebectomies
- ACRONYMSAPTAP study
- hypothesisOur hypothesis is that SAP is a cost-effective alternative to TAP. SAP will suffice in gaining a good clinical outcome without ablating the GSV in 2/3 of eligible patients after one year.
- Healt Condition(s) or Problem(s) studiedGreat saphenous vein, Venous insufficiency , Phlebectomy
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Patients >18 years
- Symptoms of chronic venous disease, including complaints related to varicose veins (patients with > C2)
- Reflux (defined as duration of reverse flow >0.5) of the AASV or GSV (at least above knee level) and refluxing tributaries at the level of the thigh (not lower than 5cm below the knee)
- Minimal length of refluxing segment > 5cm
- Diameter of the GSV or AASV ≥ 3 mm (measured in its tubular part of GSV or AASV, at mid thigh level in case of a GSV or at 3 cm below the SFJ in case of an AASV, not at focal dilatation)
- Tributaries are considered suitable for phlebectomy (in practice ≥ 3 mm)
- Informed consent
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:
- Previous treatment of the ipsilateral GSV (or in case of AASV, previous treatment of the ipsilateral AASV) or tributaries
- Non-isolated incompetence of the AASV or GSV of the ipsilateral leg
- Previous high ligation of the SFJ
- Acute deep or superficial vein thrombosis
- Agenesis of the deep venous system
- Vascular malformations
- Post-thrombotic syndrome (reflux type or obstructive type)
- Pregnancy
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2014
- planned closingdate1-nov-2017
- Target number of participants520
- InterventionsSingle ambulatory phlebectomies versus endovenous thermal ablation with concomitant ambulatory phlebectomies
- Primary outcomeCost-effectiveness
- Secondary outcome- Absence of reflux on duplex ultrasound
- Patient reported outcomes
- Cí of the CEAP classification
- Venous clinical severity score
- TimepointsBaseline, 3 months, 9 months and 1 year of follow up
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES S.K. Velden, van der
- CONTACT for SCIENTIFIC QUERIES S.K. Velden, van der
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD22-sep-2014 - 5-nov-2014


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