Coronary Stenosis, Stent Stenosis
Conditions
Keywords
PCI, stent, bifurcation, Culotte, DK-Crush, restenosis
Brief summary
Randomised comparison of Culotte technique versus Double Kissing - Crush technique (DK-Crush) for the percutaneous treatment of de novo non-left main coronary bifurcation lesions with modern everolimus-eluting stents (DES) - German multicenter study
Detailed description
Aim of study This prospective randomized multicenter study will compare the long-term safety and efficacy of Culotte stenting versus Double Kissing - Crush (DK-Crush) stenting in the treatment of the de-novo non-left main coronary bifurcation lesions with new generation everolimus-eluting stents. Study hypothesis In large coronary bifurcation lesions (main vessel \> 2.5mm, side branch \> 2.25mm) including significant ostial side branch disease, Culotte stenting compared with DKcrush stenting reduces maximal percent diameter stenosis at the bifurcation at 9-month follow-up by 25 %. Study design Prospective, randomized, German multicenter study. Methods Four-hundred patients, in whom a double-stenting technique is intended for the treatment of a non-left main de-novo coronary bifurcation lesion will be randomly assigned to Culotte stenting or to DK-crush stenting with an approved drug-eluting stent (SYNERGY-Stent). As a part of usual care, patients will undergo 9-month angiographic follow-up with quantitative coronary angiography. Clinical follow-up is planned at 1 year if no angiographic follow-up is obtained.
Interventions
PROCEDUREStenting
Comparison of two technical approaches in the interventional treatment on de-novo non-left main coronary lesions
Sponsors
University Heart Center Freiburg - Bad Krozingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Clinical indication, evidenced by angina / angina-equivalent symptoms or documented ischemia (non-invasive imaging such as scintigraphy, stress-MRI or stress-echo; FFR or iwFR) or patients with acute coronary syndromes (NSTE-ACS). 2. Clinical indication to perform double stenting only with Synergy™ stents for a clinically significant bifurcation stenosis as judged by the operator. 3. De-novo non-Ieft main coronary bifurcation lesions - 1,1,1 or 0,1,1 according to the Medina classification - of a native coronary artery with the following reference vessel diameters: main branch \> 2,5 mm; side branch \> 2,25 mm. The difference between vessel diameter of the main and side branch is ≤ 1 mm. 4. The target lesion has not been previously treated with any interventional procedure. 5. The target vessel (main branch and side branch) must appear feasible for stent implantation. 6. Patient has no other coronary intervention planned within 30 days of the procedure. 7. Patient has been informed of the nature of the study and agrees to its provisions and has written informed consent as approved by the Ethics Committee. 8. Patient is willing to comply with all required post-procedure follow-up.
Exclusion criteria
1. Patient had an acute ST-elevation myocardial infarction within 72 h preceding the index procedure or target vessel contains intraluminal thrombus. 2. Use of any other coronary stent than Synergy™ and Synergy Megatron™ except for baiI-out situations. 3. Patient with a known hypersensitivity or contraindication to the needed antithrombotic therapy, stent type or contrast media that cannot be adequately pre-medicated. 4. Non successful treatment of other lesion during the same procedure. 5. Patient with a severe bleeding diathesis, history of recent major bleeding or stroke (≤ 6 months), coagulopathy or severe liver disease. 6. Patient has a co-morbidity (i.e. cancer) that may cause the patient to be noncompliant with the protocol, or is associated with limited life-expectancy (Iess than 1 year). 7. Patient is participating in any other clinical study with an investigational product. 8. Patient is known to be pregnant or lactating at time of inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Angiographic restenosis in the bifurcation lesion by quantitative coronary analysis (QCA) | 9 months post index percutaneous coronary intervention (PCI) | For quantitative coronary angiography, changes between result at the completion of the index intervention and at 9 months follow-up will be analysed using a computer based system dedicated to bifurcation analysis, according to the standard operating procedure of the angiographic core laboratory. Quantitative angiographic measurements will be obtained of the three segments of the bifurcation lesion: the proximal and distal segment of the main branch and the side branch. We will perform measurements in the stented portion of the vessel (in-stent) and in the distal or proximal 5 mm margin (edge). In-segment analyses will comprise the in-stent and the edge area. In addition, the bifurcation angle from the analysis system will be estimated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major adverse cardiac events (MACE) | 1 year | MACE defined as death, Myocardial infarction (Q wave and Non-Q wave), emergent cardiac bypass surgery, or TLR |
| Incidence of target lesion revascularisation (TLR) | 1 year | Any revascularisation (Re-PCI or CABG) at segments treated during index procedure |
| Incidence of binary restenosis at any segment of the bifurcation lesion | 9 months | ≥ 50% diameter stenosis in the main and side branch |
| Incidence of binary restenosis in the main and side branch | 9 months | ≥ 50% diameter stenosis in main and side branch |
| Incidence of stent thrombosis (ST) | 1 year | Post-procedure thrombotic stent occlusion according to the Academic Research Consortium-criteria |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of device success | 9 months | Attainment of \< 30% residual stenosis of the target lesion in the main and side branch |
| Mean procedure time | Index Intervention | Procedure time measured in minutes |
| Mean volume of used contrast medium | Index Intervention | Contrast medium measured in milliliters |
| Mean radiation exposure | Index Intervention | Radiation exposure measured in cGym² |
Countries
Germany
Contacts
Primary ContactMiroslaw Ferenc, MD
Outcome results
None listed