BBK-3: Culotte Versus DK-CRUSH Technique in Non-left Main Coronary Bifurcation Lesions

Sponsor

University Heart Center Freiburg - Bad Krozingen (Other)

Overall Status

Recruiting

CT.gov ID

NCT04192760

Collaborator

(none)

400

Enrollment

Locations

Arms

Anticipated Duration (Months)

30.8

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Stenosis Stent Stenosis	Procedure: Stenting	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Bifurcations Bad Krozingen (BBK) 3 - Trial Randomised Comparison of Culotte-stenting Versus DK-Crush--stenting for the Treatment of de Novo Non-left Main Coronary Bifurcation Lesions With Everolimus-eluting Stents

Actual Study Start Date :

Dec 1, 2019

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Culotte Technique Both vessels have to be wired. Lesion preparation in the main vessel and side branch may be undertaken according to operator preference. After lesion preparation, the side branch has to be stented first. The first stent is placed from main branch into the side branch, covering the entire diseased segment with a wire jailed in the main vessel. The main vessel is rewired through the stent struts, and after removal of the jailed wire, is dilated with a balloon to separate stent struts. The side branch wire is then removed and the main vessel is stented covering the proximal and distal segment. The side-branch is re-wired and high pressure individual inflations are made in each vessel at the bifurcation point to ensure good stent strut separation. Afterwards, a lower pressure kissing inflation is made. Balloon sizing should be in accordance with the diameter of the vessel itself. Finally, a proximal optimization (POT) procedure is performed.	Procedure: Stenting Comparison of two technical approaches in the interventional treatment on de-novo non-left main coronary lesions
Active Comparator: DK-Crush Technique Both vessels have to be wired first. Lesion preparation in the main vessel and side branch may be undertaken according to operator preference (rotablation, if needed). After lesion preparation, the side branch is stented first. Side branch stent should have a small protrusion into the main branch. Before stent implantation in the side branch, an adequately sized balloon should be placed in the main branch, just opposite to the side branch ostium. After stent implantation in the side branch, stent balloon and wire are removed and the balloon in the main branch must be inflated, to crush the struts into the vessel wall. In next step, the new wire should be crossed into the ostium of the side branch and first kissing balloon dilatation will follow. The next step is to implant the second stent into the main branch, followed by second re-wiring, a second kissing balloon-dilatation and final proximal optimization (POT) procedure (single short balloon inflation in proximal segment).	Procedure: Stenting Comparison of two technical approaches in the interventional treatment on de-novo non-left main coronary lesions

Arm

Intervention/Treatment

Active Comparator: Culotte Technique

Both vessels have to be wired. Lesion preparation in the main vessel and side branch may be undertaken according to operator preference. After lesion preparation, the side branch has to be stented first. The first stent is placed from main branch into the side branch, covering the entire diseased segment with a wire jailed in the main vessel. The main vessel is rewired through the stent struts, and after removal of the jailed wire, is dilated with a balloon to separate stent struts. The side branch wire is then removed and the main vessel is stented covering the proximal and distal segment. The side-branch is re-wired and high pressure individual inflations are made in each vessel at the bifurcation point to ensure good stent strut separation. Afterwards, a lower pressure kissing inflation is made. Balloon sizing should be in accordance with the diameter of the vessel itself. Finally, a proximal optimization (POT) procedure is performed.

Procedure: Stenting

Comparison of two technical approaches in the interventional treatment on de-novo non-left main coronary lesions

Active Comparator: DK-Crush Technique

Both vessels have to be wired first. Lesion preparation in the main vessel and side branch may be undertaken according to operator preference (rotablation, if needed). After lesion preparation, the side branch is stented first. Side branch stent should have a small protrusion into the main branch. Before stent implantation in the side branch, an adequately sized balloon should be placed in the main branch, just opposite to the side branch ostium. After stent implantation in the side branch, stent balloon and wire are removed and the balloon in the main branch must be inflated, to crush the struts into the vessel wall. In next step, the new wire should be crossed into the ostium of the side branch and first kissing balloon dilatation will follow. The next step is to implant the second stent into the main branch, followed by second re-wiring, a second kissing balloon-dilatation and final proximal optimization (POT) procedure (single short balloon inflation in proximal segment).

Procedure: Stenting

Comparison of two technical approaches in the interventional treatment on de-novo non-left main coronary lesions

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Incidence of target lesion revascularisation (TLR) [1 year]
Any revascularisation (Re-PCI or CABG) at segments treated during index procedure
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 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 Outcome Measures

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 radiation exposure [Index Intervention]
Radiation exposure measured in cGym²
Mean volume of used contrast medium [Index Intervention]
Contrast medium measured in milliliters

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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).
Clinical indication to perform double stenting only with Synergy™ stents for a clinically significant bifurcation stenosis as judged by the operator.
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.
The target lesion has not been previously treated with any interventional procedure.
The target vessel (main branch and side branch) must appear feasible for stent implantation.
Patient has no other coronary intervention planned within 30 days of the procedure.
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.
Patient is willing to comply with all required post-procedure follow-up.

Exclusion Criteria:

Patient had an acute ST-elevation myocardial infarction within 72 h preceding the index procedure or target vessel contains intraluminal thrombus.
Use of any other coronary stent than Synergy™ and Synergy Megatron™ except for baiI-out situations.
Patient with a known hypersensitivity or contraindication to the needed antithrombotic therapy, stent type or contrast media that cannot be adequately pre-medicated.
Non successful treatment of other lesion during the same procedure.
Patient with a severe bleeding diathesis, history of recent major bleeding or stroke (≤ 6 months), coagulopathy or severe liver disease.
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).
Patient is participating in any other clinical study with an investigational product.
Patient is known to be pregnant or lactating at time of inclusion.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Heart Center Freiburg • Bad Krozingen	Bad Krozingen	Suedring 15	Germany	79189
2	Herz-u. Diabeteszentrum	Bad Oeynhausen		Germany	32545
3	Herz-und Gefäßzentrum	Bad Segeberg		Germany	23795
4	St. Johannes-Hospital	Dortmund		Germany	44137
5	Herzzentrum Dresden an der Technischen Universität	Dresden		Germany	01307
6	Elisabeth Krankenhaus	Essen		Germany	45138
7	Universitätsklinikum Gießen	Gießen		Germany	35392
8	Universitätsklinikum Leipzig	Leipzig		Germany	04103
9	Universitätsklinik Mannheim	Mannheim		Germany	68167
10	Deutsches Herzzentrum	München		Germany	80636
11	Klinikum Oldenburg	Oldenburg		Germany	26133
12	Herzzentrum Trier	Trier		Germany	54292
13	Universitätsklinikum Ulm	Ulm		Germany	89070