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Status:

COMPLETED

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

Lead Sponsor:

DK Medical Technology (Suzhou) Co., Ltd.

Collaborating Sponsors:

Core Medical (Beijing) Co., Ltd.

Conditions:

Coronary Small Vessel Disease

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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™ Inte...

Eligibility Criteria

Inclusion

  • Related to the patients:
  • Cohort A:
  • 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
  • Patients with stable angina, unstable angina, old myocardial infarction (including ST elevation MI or Non-ST elevation MI) or proven asymptomatic ischemia
  • 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
  • Patients who can receive balloon angioplasty
  • Related to lesion:
  • Cohort A
  • The reference blood vessel diameter is 2.25 mm-2.75 mm, length ≤ 26mm
  • Before surgery, stenosis diameter must be ≥ 70% or ≥ 50% and accompanied by ischemia
  • 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
  • The reference blood vessel diameter is 2.00mm-2.25mm

Exclusion

  • Related to patients
  • Patients who had Myocardial Infarction within 1 week before being included
  • Patients with severe congestive heart failure or NYHA grade IV heart failure
  • Left ventricular ejection fraction (LVEF) \< 35%
  • Patients who had heart transplantation
  • Patients with severe valvular heart disease
  • 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
  • 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)
  • Patients with renal insufficiency (eGFR \< 30mL/min)
  • Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate Aspirin or Clopidogrel
  • Patients who are allergic to Paclitaxel or Zotarolimus
  • The patients have a life expectancy of less than 12 months, or it would be difficult to finish follow-ups within 12 months
  • Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives
  • The patients are participating in any other clinical trials before reaching the primary endpoints
  • Patients who are unsuitable for the study according to the investigator due to other reasons
  • Related to the Lesion:
  • Patients with total occlusion at the target lesion
  • Patients who have severe calcification of the target lesion, and balloon pre-dilatation could not be performed successfully
  • The target lesions are bifurcation lesion with the diameter of the branch vessel \> 2.00mm
  • The target lesions are in-stent restenosis
  • Angiography indicates thrombosis in the target vessel
  • Complicated with lesions in left main (LM) coronary requiring intervention treatment
  • More than 2 non-target lesions need treatment, or the non-target lesion could not be intervened successfully before the target lesion

Key Trial Info

Start Date :

June 20 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 15 2024

Estimated Enrollment :

277 Patients enrolled

Trial Details

Trial ID

NCT03376646

Start Date

June 20 2018

End Date

April 15 2024

Last Update

February 20 2025

Active Locations (15)

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Page 1 of 4 (15 locations)

1

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

2

Beijing Friendship Hospital, Capital Medical University

Beijing, China

3

Beijing Hospital

Beijing, China

4

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, China