The Study of Active Transfer of Plaque Technique for Unprotected Distal Left Main Bifurcation Lesions

Coronary Heart Disease Clinical Trial

Official title:

A Prospective Multicenter Randomized Trial Assessing the Efficacy and Safety of Active Transfer of Plaque vs. Provisional T Stenting for the Treatment of Unprotected Distal Left Main Bifurcation Lesions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02127138
• Other study ID #: ATP 01
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2015
• Est. completion date: December 2021

Study information

• Verified date: January 2020
• Source: Beijing Anzhen Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Prospective Multi-center Randomized Trial Assessing the Efficacy and Safety of Active Transfer of Plaque vs. Provisional T Stenting for the Treatment of Unprotected Distal Left Main Bifurcation Lesions

Description:

It is a prospective, multi-center, randomized, open-label, non-inferiority trial. A total of 316 subjects from around 20 selected hospitals will be randomized on a 1:1 basis to either Active transfer of Plaque (ATP) stenting technique or Provisional T stenting technique.

In the ATP treatment of bifurcation lesions, by the balloon pre-dilation in the target side branch, the plaque will be actively transferred from side branch to main vessel. Subsequently, the plaque will be fixed by the expansive stent in main vessel.As to the provisional T treatment, provisional T stenting is the typic step-T stenting. In brief, two wires are advanced to distal MV and SB. Pre dilation is left at operator's discretion, however, pre dilating SB is not encouraged. Kissing balloon inflation before stenting MV is left at operator's discretion. A stent with stent/artery ratio of 1.1:1 is inflated in MV. Rewire to SB is also left at operator's discretion. FKBI is recommended if there is at least one of following: residual stenosis>70%, >type B dissection and TIMI flow<3.

All patients will be followed clinically at 1-, 6- 12- and 24-month after stent implantation. Repeat angiography will be performed in all patients at 13 months after the index procedure.

The primary endpoint of the trial is the rate of TLR at 12-month follow-up.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 316
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient must be at least =18, =80 years of age.

• Patient has Stable/unstable angina or NSTEMI

• Patient has STEMI>24-hour from the onset of chest pain to admission.

• LMb (Medina 0,1,1;1,1,1;0,1,0 ;1,1,0).

• Patient is eligible for elective percutaneous coronary intervention (PCI) .

• Patient is an acceptable candidate for coronary artery bypass grafting (CABG).

• Patient (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed; patient is willing to comply with all protocol-required follow-up evaluations

Exclusion Criteria:

• Patient with STEMI (within 24-hour from the onset of chest pain to admission).

• Patient has known allergy to the study stent system or protocol-required concomitant medications that cannot be adequately pre-medicated (everolimus, aspirin, contrast media, acrylic acid, Stainless steel).

• Patient has intolerable to dual anti-platelet therapy.

• Patient has any other serious medical illness that may reduce life expectancy to less than 12 months.

• Patient is pregnant or nursing.

• Patient is participating in another clinical trial that has not reached its primary endpoint within 12 months after the index procedure.

• Patient with severe calcified lesions needing rotational atherectomy.

• Left main In Stent Restenosis.

• Investigator consider that patients don't fit to participate in the study.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Device:
• Sirolimus eluting Drug stent
Use the Sirolimus-eluting Drug stents has been approved by the CFDA,But does not allow use taxol-eluting Drug stents and Drug-eluting stent without Polymer.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (8)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital	Beijing Jishuitan Hospital, General Hospital of Ningxia Medical University, Taihe Hospital, Tangshan Worker's Hospital, The Fourth Affiliated Hospital of Harbin Medical University, Tianjin Chest Hospital, Tianjin First Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The release of procedure-related biomarker		baseline
Other	Consumption of devices for surgery procedure		baseline
Other	Amount of contrast agent		baseline
Other	Procedure time		baseline
Other	X-ray exposure time		baseline
Other	X-ray dose		baseline
Other	DAP-total, DAP-record, DAP-fluoro		baseline
Other	contrast induced acute kidney injury (CIAKI)		3 days after the procedure
Primary	Rate of target lesion revascularization (TLR) at 12-month.		12 months
Secondary	Rate of target lesion failure(TLF) at 1-, 6-,12- and 24-month after procedure		Up to 2years
Secondary	Clinically cardiovascular endpoints at 1-, 6- , 12- and 24-month, including all-cause death, MI and any revascularization.		Up to 2 years
Secondary	Stent thrombosis which is defined according to Academic Research Consortium (ARC) definition, including definite, probable and possible stent thrombosis.		Up to 2 years
Secondary	Classification score of Canadian Cardiovascular Society (CCS) angina or Braunwald class.		Up to 2 years
Secondary	The net gain of lumen diameter; in-segment late loss (LL) and ISR of main vessel and side branch at 13-month.		13 months