China Resolute Integrity 34/38 mm Study

NCT03118531 | Completed

• 1 other identifier: MDT16003RES001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the clinical safety and efficacy in Chinese subjects, eligible for percutaneous transluminal coronary angioplasty (PTCA) in lesions amenable to treatment with a 34/38 mm Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System.

Conditions

Ischemic Heart Disease; Stenotic Coronary Lesion; Cardiovascular Diseases; Arteriosclerosis; Coronary Artery Disease

Keywords

Long Lesion; In-stent Late Lumen Loss (LLL); Major Adverse Cardiac Events (MACE); MYOCARDIAL INFARCTION (MI); TARGET VESSEL REVASCULARIZATION (TVR); TARGET LESION REVASCULARIZATION (TLR); Target Vessel Failure (TVF); Target Lesion Failure (TLF); Stent Thrombosis (ST)

Outcome Measures

Primary Outcomes (1)

• Late lumen loss, in stent

  Late lumen loss measured by quantitative coronary angiography (QCA)

  9 months (m)

Secondary Outcomes (14)

• Major Adverse Cardiac Events (MACE)

  30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years

• Death

  30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years

• Myocardial infarction

  30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years

• All revascularizations

  30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years

• Target Vessel Failure (TVF)

  30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years

Study Arms (1)

Coronary Stent

EXPERIMENTAL

Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System (34/38 mm)

Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm)

Interventions

Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm) DEVICE

The stenting procedure should be performed according to the Instructions for Use that is provided with each 34/38 mm Resolute Integrity stent.

Coronary Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the Instructions for Use of the Resolute Integrity 34/38 mm stent
• The subject can have either a single lesion, or two lesions located in separate target vessels treated during the index procedure. Each lesion length needs to be ≤35mm with at least one lesion length \>27mm and≤ 35mm and amenable for treatment with a Resolute Integrity 34/38 mm stent

You may not qualify if:

• STEMI within 24 hours
• Left main disease
• Bifurcation disease

Sponsors & Collaborators

• Medtronic Vascular: lead

Study Sites (2)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100000, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

MeSH Terms

Conditions

Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Coronary Artery Disease; Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart Diseases; Vascular Diseases; Arterial Occlusive Diseases; Coronary Disease; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Lianglong Chen, MD

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 18, 2017
• Study Start: April 17, 2017
• Primary Completion: July 31, 2018
• Study Completion: April 28, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

CN (2)