萝莉社

The purpose of this study is to compare the efficacy (how well it works) and safety of the MagicTouch^TM Sirolimus-Coated Balloon in small vessel disease compared to standard of care drug eluting stents (DES) in humans.

Clinical inclusion criteria:

1. Adult patient with an indication for PCI due to small vessel coronary

artery disease

2. Subject is ≥18 and <80 years old

3. Subject (or legal guardian) is willing to comply with all protocol-required follow-up

evaluations and provides written informed consent

Angiographic inclusion criteria:

1. Target reference vessel diameter (RVD; visual estimation) ≤2.75 mm

2. Successful and uncomplicated lesion preparation defined as: visually estimated

residual DS <30% in 2 near-orthogonal projections, post-procedure TIMI Grade 3

flow (as visually assessed), no flow-limiting dissection, no perforation, no persistent

ST segment changes, no prolonged chest pain, no BARC type 3 bleeding

3. Target lesion(s) in native coronary artery

4. Up to two small vessel target lesions in two different vessels

5. Target lesion length (visual estimation): ≤36.0 mm and can be covered by a single 40

mm balloon.

6. Target lesion must have visually estimated stenosis ≥50% and ≤100% diameter

stenosis in symptomatic subjects; or a visually estimated target lesion diameter

stenosis of ≥70%, or fractional flow reserve (FFR) ≤0.80 or non-hyperemic pressure

ratio (NHPR) ≤0.89 in absence of symptoms

7. Target lesion diameter stenosis (visual estimation) >50% and ≤100% with

Thrombolysis in Myocardial Infarction (TIMI) flow grade ≥1

 

Exclusion Criteria

Clinical exclusion criteria:

1. Planned (staged) intervention in the target vessel

2. Subjects who have received non-target lesion DCB treatment within the past 30 days

or any prior target lesion DCB treatment (includes coronary or off-label peripheral

DCB)

3. ST-segment-elevation MI (STEMI) within 48 hours prior to index procedure

4. NSTEACS in whom the biomarkers have not peaked

5. Subjects with acute cardiac decompensation or cardiogenic shock

6. Subject with a life expectancy of less than 24 months

7. Impaired renal function (glomerular filtration rate [GFR] <30 mL/min)

8. Documented left ventricular ejection fraction (LVEF) ≤30%

9. Known allergies to acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor, heparin,

bivalirudin, iodinated contrast medium, sirolimus or similar drugs (i.e., ABT-578

[Zotarolimus], biolimus, tacrolimus)

10. Relative or absolute contraindication to dual antiplatelet therapy (DAPT) for at least

1 month (e.g., planned surgeries that cannot be delayed)

11. Subject has an indication for chronic oral anticoagulation treatment and a

contraindication for concomitant treatment with a P2Y12 inhibitor

12. If femoral access is planned, significant peripheral arterial disease which precludes

safe insertion of a 6F sheath

13. Hemoglobin <9 g/dL

14. Platelet count <100,000 cells/mm3 or >700,000 cells/mm3

15. White blood cell count <3,000 cells/mm3

16. Active infection undergoing treatment

17. Clinically significant liver disease

18. Cerebrovascular accident (CVA) within 3 months or has any permanent neurological

defect as a result of CVA

19. Patient has received an organ transplant or is on a waiting list for an organ transplant

20. Patient has received chemotherapy within 30 days before the index procedure or

scheduled to receive chemotherapy any time after the index procedure

21. Subject is receiving oral or intravenous immunosuppressive therapy or has known

life-limiting immunosuppressive or autoimmune disease. Inhaled steroid and steroid

use for contrast-allergy prophylaxis or treatment are allowed. Subjects with wellcontrolled

immunosuppressive or auto-immune conditions which are not perceived

to be life-limiting are eligible.

22. Subject is unlikely to comply with the follow up requirements, per investigator’s

assessment

23. Subject currently enrolled in other investigational device or drug trial in which

primary endpoint has not been reached

24. Pregnant and/or breast-feeding females or females who intend to become pregnant

during the time of the study

Angiographic exclusion criteria:

All exclusion criteria apply to the target lesion(s) or target vessel(s)

1. Re-stenotic lesion(s), whether due to percutaneous old balloon angioplasty (POBA)

or prior stenting*

2. True bifurcation lesion (lesion involves both main and side branch>2.5 mm) with

planned treatment of both branches per investigator assessment*

3. Angiographic evidence of thrombus in the target vessel*

4. Myocardial bridging

5. Target lesion is heavily calcified*

6. Diffuse distal disease to target lesion with impaired runoff, TIMI flow <2

7. Non-target lesion in the target vessel requiring PCI

8. Target lesion is a chronic total occlusion* (or subtotal occlusion) without adequate

lesion preparation. Total and subtotal occlusions may be enrolled assuming they can

be crossed with a wire and demonstrate TIMI grade 3 flow after adequate lesion

preparation at the time of randomization.

Note: Non-target lesion PCI are allowed in non-target vessels to be treated with

approved interventional devices prior to randomization as follows:

§ During index procedure: PCI of non-target lesions performed during the

baseline procedure itself immediately prior to randomization if successful

and uncomplicated defined as: non- target lesion crossed and intervened on

with <30% visually estimated residual diameter stenosis in 2 nearorthogonal

projections, post-procedure TIMI Grade 3 flow (as visually

assessed), no flow-limiting dissection, no perforation, no persistent ST

segment changes, no prolonged chest pain, no TIMI major or BARC type 3

bleeding

§ Less than 24 hours prior to index procedure: Not allowed

§ Between 24 hours - 30 days prior to index procedure: PCI to non-target

lesion prior to randomization was successful and uncomplicated (as

defined above). In cases where PCI was performed <72 hours prior to

baseline procedure, 2 sets of cardiac biomarkers must be drawn after

non-target lesion PCI, and if elevated, serial measurements must

demonstrate that biomarkers are falling

§ Over 30 days prior to index procedure: PCI of non-target lesions

performed greater than 30 days prior to procedure whether or not

successful and uncomplicated