Collection of Information on the long-term results of treatment with the Supraflex™ Cruz drug-releasing blood vessel scaffold

Prospective evaluation of thin-strut biodegradable polymer-coated Supraflex sirolimus-eluting stents in an all-comers patient population (S-FLEX UK-II)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN39751665

Enrollment

3000

Registered

2020-07-01

Start date

2020-03-10

Completion date

Unknown

Last updated

2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherothrombosis Circulatory System Atherothrombosis

Interventions

Once a patient has been identified as potentially meeting the inclusion and exclusion criteria written informed consent is obtained prior to the patient’s enrollment. Potential participants will have

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older 2. Symptomatic coronary disease 3. Clinical indication for PCI and stenting of at least one coronary lesion visually confirmed on coronary angiography 4. Only Supraflex Cruz stent(s) is/are to be implanted into the coronary vasculature during the index procedure 5. Give informed consent to participate in this registry and sign the informed consent form approved by the institutional review board of each registry site before the index PCI 6. Agree to undergo all clinical follow-up procedures specified in the study protocol (S-FLEX UK-II) for this registry

Exclusion criteria

Exclusion criteria: 1. Cardiogenic shock. 2. Pregnant or possibly pregnant 3. Known hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, sirolimus or contrast media 4. Scheduled to undergo elective surgery within 12 months post-index PCI 5. Currently participating in a clinical study of another drug or medical device and in whom assessment of the primary endpoint of that study has not been completed or clinically interferes with the endpoints of this registry 6. Mental incapacity, unwillingness or language barrier precluding understanding of the registry procedure or cooperation with registry site personnel

Design outcomes

Primary

Measure	Time frame
The safety and efficacy of the Supraflex Cruz stent measured through patient interviews and the review of medical notes at the 12 month follow up	—

Secondary

Measure	Time frame
Measured using a review of patient records: 1. Procedural endpoints [at the end of the index procedure (12 months)] 1.1. Device success, lesion success, procedural success 2. Safety and efficacy endpoints [30 days and 12 months] 2.1. Overall stent thrombosis 2.2. All deaths (cardiac, vascular and non-cardiovascular) 2.3. Any myocardial infarction (Q wave and non-Q wave MI) 2.4. Any repeat revascularization (target lesion and target vessel revascularization) 2.5. Target Lesion Failure (TLF) 2.6. Target Vessel Failure (TVF): a composite endpoint of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization	—

Measure

Time frame

Measured using a review of patient records: 1. Procedural endpoints [at the end of the index procedure (12 months)] 1.1. Device success, lesion success, procedural success 2. Safety and efficacy endpoints [30 days and 12 months] 2.1. Overall stent thrombosis 2.2. All deaths (cardiac, vascular and non-cardiovascular) 2.3. Any myocardial infarction (Q wave and non-Q wave MI) 2.4. Any repeat revascularization (target lesion and target vessel revascularization) 2.5. Target Lesion Failure (TLF) 2.6. Target Vessel Failure (TVF): a composite endpoint of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization

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Countries

England, United Kingdom, Wales

Contacts

Public ContactManoj Virupil

manoj@smt.in+353 91397472

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026