IVUS-guided stenting technique for complex coronary bifurcation lesions

Comparison of Intravascular Ultrasound-guided With Angiography-guided Double Kissing Crush Stenting Technique for Patients With Complex Coronary Bifurcation Lesions: The Prospective, Multi-center, Randomized DKCRUSH VIII Trial

This study is testing if a new stenting technique guided by ultrasound can help people with complex heart artery blockages do better than the traditional method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 556 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nanjing First Hospital, Nanjing Medical University (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT03770650 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of the IVUS-guided DK crush stenting technique compared to the traditional angiography-guided approach in patients with complex bifurcation lesions. It is a prospective, multi-center, randomized-controlled trial involving 35 international sites and aims to enroll 556 subjects. Participants will be randomly assigned to one of the two stenting techniques and will be monitored for target vessel failure over a 12-month period. Data will be collected during the procedure and at follow-up visits to assess outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with complex bifurcation lesions suitable for drug-eluting stent implantation.

Not a fit: Patients who are pregnant, have a life expectancy of less than 12 months due to co-morbidities, or cannot comply with follow-up requirements may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved outcomes for patients with complex coronary bifurcation lesions, reducing the risk of cardiac events.

How similar studies have performed: Other studies have shown promising results with IVUS-guided techniques, suggesting potential benefits in similar patient populations.

Eligibility criteria

Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures;
2. Men and women 18 years and older;
3. Established indication for PCI according to the guidelines of ACC/AHA;
4. Native coronary lesion suitable for drug-eluting stent placement;
5. True bifurcation lesions (Medina 0,1,1/1,1,1), lesions length≤ 68 mm
6. Reference vessel diameter in side branch \> 2.5mm by visual estimation;
7. Complex bifurcation lesions based on the DEFINITION study.

Exclusion Criteria:

1. Pregnancy and breast feeding mother;
2. Co-morbidity with an estimated life expectancy of \< 50 % at 12 months;
3. Scheduled surgery interrupting antiplatelet medications in the next 6 months;
4. Intolerable to DAPT;
5. Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
6. Unable to provide written informed consent, or fail to follow the protocol;
7. Previous enrolment in coronary intervention device investigation during the study period;
8. Lesion cannot be covered by 2 longest stents;
9. Restenotic bifurcation lesions；
10. Severe calcification requiring rotational atherectomy;
11. Acute myocardial infarction less than 24 hours;
12. Chronic total occlusion which is not recanalized;
13. Simple bifurcation lesions;
14. Renal failure requiring or during dialysis;
15. Hemoglobin \<9g/L
16. Uncontrolled hypertension (systolic blood pressure≥180 mmHg or diastolic blood pressure≥110 mmHg)
17. Severe heart failure (LVEF\<30%)
18. Combined pre- and post-capillary hypertension (mPAP≥25 mmHg, PCWP\>15 mmHg, and PVR\>3.0 WU)
19. Patients with hypertrophic obstructive cardiomyopathy.

Where this trial is running

Nanjing, Jiangsu

• Nanjing First Hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Shao-Liang Chen, MD, PhD

Conditions Coronary Artery Disease