An interventional study of AXXESS + Biomatrix Biolimus Eluting stent and Culotte technique with Xience V or Xience Prime stents in True Coronary Bifurcation Lesions, sponsored by Universitaire Ziekenhuizen KU Leuven. Status unknown at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-09.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Treatment
Treatment of bifurcation lesions with drug-eluting stents (DES) (especially when a double stent technique is used) is associated with a higher risk for stent thrombosis. Different factors may play a role in the higher risk for stent thrombosis in bifurcation lesions. Possible mechanisms are delayed endothelialisation due to the action of the drug, coating polymers, or overlapping stent segments, incomplete stent apposition at specific sites in the bifurcation lesion and higher thrombogenicity due to turbulent flow at the bifurcation site. In human pathological data, the RUTSS (ratio of uncovered to total stent struts) appears to be the most powerful predictor of stent thrombosis.
This prospective study will assess the differences in stent strut coverage and stent strut apposition after complex bifurcation lesion treatment with the dedicated AXXESS Biolimus A9-eluting bifurcation stent at the bifurcation site and additional Biomatrix Biolimus A9-eluting stents in the distal main vessel and the side branch versus treatment with the culotte technique using the Xience Prime everolimus-eluting stents.
BACKGROUND: There is an ongoing controversy over the efficacy and safety of different bifurcation stenting techniques. Critical considerations are the rate of restenosis at the side branch ostium, and completeness of healing at sites of overlap of stent struts, which may affect the risk of stent thrombosis.
AIMS: To compare vessel healing at 9 months using OCT imaging for two different treatment techniques for treating bifurcation lesions. Quantitative assessment of OCT images will be used to assess re-endothelialisation and quality of strut apposition to the vessel wall.
METHODS: Patients with true bifurcation lesions with involvement of a significant side branch requiring a stent will be randomly assigned to one of two treatment strategies. Group A will comprise 20 patients which will be treated with the Axxess™ Drug Eluting Coronary Bifurcation Stent System (Biosensors Europe SA) where additional Biomatrix™ Drug Eluting Coronary Stent Systems (Biosensors Europe SA) are implanted into the distal main branch (MB) and the side branch (SB) as required. Group B will consist of 20 patients which will be treated with the culotte technique using Xience Prime everolimus-eluting stents (Abbott-Vascular, US). Kissing balloon dilatation using non-compliant balloons will complete the index procedure in all cases. At 9 months, control angiography for all patients (with QCA using dedicated software) and OCT (of both main vessel and side branch) will be performed.
ENROLMENT PLAN:
Start: Third quarter of 2011 Enrolment period: ± 12 months Clinical follow-up: 5 years Angiographic and OCT results expected third quarter of 2013
Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
After mandatory predilatation, a self-expanding, conically shaped nickel-titanium AXXESS biolimus A9-eluting stent is placed at the level of the carina. The device is available in 3.0 and 3.5 mm calibre and 11 and 14 mm length. Depending on the lesion anatomy, additional Biomatrix™ Drug Eluting Coronary Stent Systems are placed distally if necessary. The procedure is completed with kissing balloon postdilatation using non-compliant balloons sized to the reference vessel diameter of the distal branches. Before this kissing balloon inflation, consecutive high pressure inflations should be performed in both branches.
Device: AXXESS + Biomatrix Biolimus Eluting stent
The culotte technique consists of stenting one of both branches of the bifurcation lesion first, and after balloon dilatation of the stent meshes, stenting the uncovered branch through the first stent and leaving the main vessel covered with two overlapped stents. The procedure is terminated by kissing balloon dilatation of both branches using non-compliant balloons sized to the reference vessel diameter of the distal branches. Before this kissing balloon inflation, consecutive high pressure inflations should be performed in both branches.
Device: Culotte technique with Xience V or Xience Prime stents
NAP
NAP
Primary endpoint
Percent uncovered to total stent struts at 9 months, assessed with OCT, in two different bifurcation stenting techniques
Time frame: 9 months
Secondary endpoint : stent strut coverage per segment with OCT
- Percent uncovered to total stent struts at 9 months per analyzed bifurcation segment (proximal MB, carina, distal MB, SB)
Time frame: 9 months
Secondary endpoint: stent strut apposition with OCT
- Percent malapposed to total stent struts at 9 months post procedure, both overall and per bifurcation segment
Time frame: 9 months
Secondary endpoint: clusters of malapposition with OCT
- Number of clusters of malapposition, overall and per bifurcation segment. Per cluster, the number of malapposed struts, the area (mm²), the volume (mm³) and the arc (degrees) of malapposition will be assessed.
Time frame: 9 months
Secondary endpoint: Tissue strut thickness with OCT
- Tissue strut thickness at 9 months per bifurcation segment (µm)
Time frame: 9 months
Secondary endpoint: neointimal hyperplasia volume
- Neointimal hyperplasia: absolute and percent volume of intimal hyperplasia at 9 months post procedure (mm³)
Time frame: 9 months
Secondary endpoint: late luminal loss (angiography)
- Late Lumen Loss (in-stent) at 9 months
Time frame: 9 months
Secondary endpoint: in-segment late luminal loss (angiography)
- In-segment Late Lumen Loss at 9 months (including stent + 5mm proximal and distal)
Time frame: 9 months
Secondary endpoint: binary restenosis (angiography)
- Binary in-stent restenosis at 9 months
Time frame: 9 months
Secondary endpoint: binary in-segment restenosis (angiography)
- Binary in-segment restenosis at 9 months (including stent + 5mm proximal and distal)
Time frame: 9 months
Secondary endpoint: minimal lumen diameter (angiography)
- Minimal Lumen Diameter (MLD), in-stent and in-segment at 9 months
Time frame: 9 months
Secondary endpoints: clinical: MACE
- Cumulative MACE rate (cardiac death, Q- or non-Q-wave MI, or clinically driven TLR) at 1, 8 and 12 months and annually for 5 years from the procedure date.
Time frame: 1, 8 and 12 months and annually for 5 years from the procedure date
Secondary endpoints: clinical: components of MACE: cardiac death
- Cumulative components of MACE: cardiac death at 1, 8 and 12 months and annually for 5 years from the procedure date.
Time frame: 1, 8 and 12 months and annually for 5 years from the procedure date
Secondary endpoints: clinical: components of MACE: Q- or non-Q-wave myocardial infarction
- Cumulative components of MACE :Q- or non-Q-wave MI at 1, 8 and 12 months and annually for 5 years from the procedure date.
Time frame: 1, 8 and 12 months and annually for 5 years from the procedure date
Secondary endpoints: clinical: components of MACE: clinically driven target lesion revascularization (TLR)
- Cumulative components of MACE : clinically driven TLR at 1, 8 and 12 months and annually for 5 years from the procedure date.
Time frame: 1, 8 and 12 months and annually for 5 years from the procedure date
Secondary endpoint: Stent thrombosis
- Stent thrombosis at at 24h, 1 month, 12 months and yearly thereafter (up to 5y)
Time frame: 24h, 1 month, 12 months and yearly thereafter (up to 5y)
Secondary endpoint: Target vessel revascularization
- Target vessel revascularisation (TVR) at at 1, 8, 12 months and yearly thereafter (up to 5y)
Time frame: 1, 8, 12 months and yearly thereafter (up to 5y)
Secondary endpoint: all-cause death
- All-cause death at 1, 8, 12 months and yearly thereafter (up to 5y)
Time frame: 1, 8, 12 months and yearly thereafter (up to 5y)
Secondary endpoint: non-target revascularization
non-Target vessel revascularization at 1, 8, 12 months and yearly thereafter (up to 5y)
Time frame: 1, 8, 12 months and yearly thereafter (up to 5y)
Secondary endpoint: any coronary revascularization
Any coronary revascularization 1, 8, 12 months and yearly thereafter (up to 5y)
Time frame: 1, 8, 12 months and yearly thereafter (up to 5y)
Secondary endpoint: device success
- Device success, defined as achievement of a final residual diameter stenosis of \<30% measured by QCA.
Time frame: Immediately after initial treatment of the study lesion
Secondary endpoint: lesion treatment success
- Lesion treatment success, defined as \<30% residual stenosis in the MB and \<50% in the SB measured by QCA by any treatment.
Time frame: Immediately after initial treatment of the study lesion
Secondary endpoint: procedure success
- Procedure success, defined as lesion success without the occurrence of MACE during the hospital stay.
Time frame: 24h after treatment of the target lesion
This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universitaire Ziekenhuizen KU Leuven