NCT03770650Active, not recruiting
IVUS-guided DK Crush Stenting Technique for Patients With Complex 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
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
This study is designed to investigate whether IVUS-guided DK crush stenting technique compared to angiography-guided DK crush after the indexed procedure will lead to lower rates of the composite endpoint of target vessel failure (TVF) at 12 months. The individual components of TVF include cardiac death, target-vessel myocardial infarction (MI), or target vessel revascularization (TVR). Complex bifurcation lesions were defined according to DEFINITION study.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 556 (actual)
- First submitted
- 6 Dec 2018
- Start date
- 26 Dec 2018
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical University
- Diseases
- Coronary artery disease
- NCT number
- NCT03770650
What you commit to
- Study type: Interventional
- Participants enrolled: 556
- From 26 Dec 2018 to the primary completion date, 30 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Scheduled surgery interrupting antiplatelet medications in the next 6 months;
- Previous enrolment in coronary intervention device investigation during the study period;
Other illness
- Acute myocardial infarction less than 24 hours;
- Renal failure requiring or during dialysis;
- Uncontrolled hypertension (systolic blood pressure≥180 mmHg or diastolic blood pressure≥110 mmHg)
- Combined pre- and post-capillary hypertension (mPAP≥25 mmHg, PCWP\>15 mmHg, and PVR\>3.0 WU)
Lab values
- Hemoglobin \<9g/L
- Severe heart failure (LVEF\<30%)
Other
- Pregnancy and breast feeding mother;
- Co-morbidity with an estimated life expectancy of \< 50 % at 12 months;
- Intolerable to DAPT;
- 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;
- Unable to provide written informed consent, or fail to follow the protocol;
- Lesion cannot be covered by 2 longest stents;
- Restenotic bifurcation lesions；
- Severe calcification requiring rotational atherectomy;
- Chronic total occlusion which is not recanalized;
- Simple bifurcation lesions;
- Patients with hypertrophic obstructive cardiomyopathy.
Who the study is looking for
- Provision of informed consent prior to any study specific procedures;
- Men and women 18 years and older;
- Established indication for PCI according to the guidelines of ACC/AHA;
- Native coronary lesion suitable for drug-eluting stent placement;
- True bifurcation lesions (Medina 0,1,1/1,1,1), lesions length≤ 68 mm
- Reference vessel diameter in side branch \> 2.5mm by visual estimation;
- Complex bifurcation lesions based on the DEFINITION study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing First Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
Related publications
- IVUS or Angiography Guidance for Percutaneous Coronary Intervention in Complex Coronary Bifurcation Lesions: The DKCRUSH VIII Randomized Clinical Trial.J Am Coll Cardiol · 2026 · PMID 41914946
This page is information, not medical advice. Discuss any trial with your doctor.