A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary Small Vessel Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

277 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-20

Study Completion Date

2024-04-15

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety in the treatment of Coronary Small Vessel Disease by drug coated balloon (DCB) Dissolve™ versus drug eluting stent (DES) Resolute™ Integrity.

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Detailed Description

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Conditions

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Coronary Small Vessel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort A: Dissolve™

Group Type EXPERIMENTAL

Cohort A: Dissolve™

Intervention Type DEVICE

Dissolve™ are to be used in the trial

Cohort A: Resolute™ Integrity

Group Type ACTIVE_COMPARATOR

Cohort A: Resolute™ Integrity

Intervention Type DEVICE

Resolute™ Integrity are to be used in the trial

Cohort B: Dissolve™-2.00mm

Cohort B is single arm.

Group Type EXPERIMENTAL

Cohort B: Dissolve™-2.00mm

Intervention Type DEVICE

Dissolve™ are to be used in the trial

Interventions

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Cohort A: Dissolve™

Dissolve™ are to be used in the trial

Intervention Type DEVICE

Cohort A: Resolute™ Integrity

Resolute™ Integrity are to be used in the trial

Intervention Type DEVICE

Cohort B: Dissolve™-2.00mm

Dissolve™ are to be used in the trial

Intervention Type DEVICE

Other Intervention Names

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Paclitaxel coated balloon Zotarolimus eluting stent

Eligibility Criteria

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Inclusion Criteria

Related to the patients:

Cohort A:

1. Patients who agree to accept the angiography follow-up visit at 9-month and follow up visits at 1-month, 6-month, 9-month, 1-year, 2-year, 3-year, 4-year and 5-year
2. Patients with stable angina, unstable angina, old myocardial infarction (including ST elevation MI or Non-ST elevation MI) or proven asymptomatic ischemia
3. Patients who can receive any kind of coronary revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting)

Cohort B: All candidates for Cohort B of this study must meet number 1, 2 of the above criteria and
4. Patients who can receive balloon angioplasty

Related to lesion:

Cohort A
5. The reference blood vessel diameter is 2.25 mm-2.75 mm, length ≤ 26mm
6. Before surgery, stenosis diameter must be ≥ 70% or ≥ 50% and accompanied by ischemia
7. One subject is allowed to have 1 target lesion at most (Two lesions can be treat as one target lesion, if they are in the same vessel, with the distance less than 10mm, with total length ≤ 26mm, and can be intervened by one DCB or DES)

Cohort B: All candidates for Cohort B of this study must meet number 6,7 of the above criteria and
8. The reference blood vessel diameter is 2.00mm-2.25mm

Exclusion Criteria

Related to patients

1. Patients who had Myocardial Infarction within 1 week before being included
2. Patients with severe congestive heart failure or NYHA grade IV heart failure
3. Left ventricular ejection fraction (LVEF) \< 35%
4. Patients who had heart transplantation
5. Patients with severe valvular heart disease
6. The patients had cerebral stroke within 6 months before being included, or have a history of peptic ulcer or gastrointestinal bleeding, or the patients have a bleeding tendency according to the investigator
7. Patients with leukopenia (white blood cell count \< 3×10\^9/L) for more than three days; Patients with low neutrophil counts (ANC \< 1000/mm\^3) for more than three days; Patients with thrombocytopenia (platelet count \< 100,000/mm\^3)
8. Patients with renal insufficiency (eGFR \< 30mL/min)
9. Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate Aspirin or Clopidogrel
10. Patients who are allergic to Paclitaxel or Zotarolimus
11. The patients have a life expectancy of less than 12 months, or it would be difficult to finish follow-ups within 12 months
12. Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives
13. The patients are participating in any other clinical trials before reaching the primary endpoints
14. Patients who are unsuitable for the study according to the investigator due to other reasons

Related to the Lesion:
15. Patients with total occlusion at the target lesion
16. Patients who have severe calcification of the target lesion, and balloon pre-dilatation could not be performed successfully
17. The target lesions are bifurcation lesion with the diameter of the branch vessel \> 2.00mm
18. The target lesions are in-stent restenosis
19. Angiography indicates thrombosis in the target vessel
20. Complicated with lesions in left main (LM) coronary requiring intervention treatment
21. More than 2 non-target lesions need treatment, or the non-target lesion could not be intervened successfully before the target lesion

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No