Clinical trial NCT02996318: Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon or a Paclitaxel Coated Balloon
Official title: Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon or a Paclitaxel Coated Balloon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: DES In-stent Stenosis
Lead sponsor: InnoRa GmbH
Sponsor class: INDUSTRY
First posted: 2016-12-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis.

Detailed description: The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis.

Patient population will consist of male and female adults suffering from coronary drug-eluting stent (DES) restenosis, which is to be treated by a study balloon according to the inclusion and exclusion criteria as defined below.

In Late lumen loss lesion (difference between the angiographic in-lesion MLD post procedural and at 6 months follow-up) will be evaluated by quantitative coronary angiography (QCA).

The study will be performed as a single-blind, SQP controlled study in 4 - 6 study centers in 50 patients.

Eligibility criteria: Inclusion Criteria:

* 18 years of age
* Clinical evidence of stable or unstable angina (acute coronary syndrome) or a positive functional study
* Patients with ≤ 2 primary drug-eluting stent in-stent restenosis (DES-ISR) lesions (≥ 70% diameter stenosis by visual estimation or ≥ 50% and positive functional study) including margin stenosis with max 5mm distance to the stent.

Exclusion Criteria:

* Chronic renal insufficiency with serum creatinine levels \> 2.0 mg per deciliter
* Known hypersensitivity or contraindications to aspirin, heparin, clopidogrel, ticlopidine or sirolimus, and sensitivity to contrast media not amenable to premedication
* Concomitant medical illness associated with a life-expectancy of less than two year
* Lesion length (ISR) \> 35 mm, vessel diameter \< 2.5 mm

Primary outcomes:
measure: Late lumen loss
timeFrame: 6 months
Secondary outcomes:
measure: Procedural Success
timeFrame: 24 hours
measure: MACE (Major adverse cardiac events)
timeFrame: 12 months
Other outcomes:
Locations:
city: Kota Kinabalu
country: Malaysia
facility: Queen Elizabeth Hospital II
city: Kuala Lumpur
country: Malaysia
facility: National Heart Institute
city: Kuala Lumpur
country: Malaysia
facility: University Malaya
city: Kuching
country: Malaysia
facility: Sarawak Genaral Hospital Heart Centre
city: Pulau Pinang
country: Malaysia
facility: Hospital Pulau Pinang
Study officials:
References:
citation: Scheller B, Mangner N, Abdul Kader MASK, Wan Ahmad WA, Jeger R, Wohrle J, Ong TK, Liew HB, Gori T, Mahfoud F, Nuruddin AA, Woitek F, Abidin IZ, Schwenke C, Schnorr B, Mohd Ali R. Combined Analysis of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions. Circ Cardiovasc Interv. 2022 Sep;15(9):e012305. doi: 10.1161/CIRCINTERVENTIONS.122.012305. Epub 2022 Sep 20.
citation: Ali RM, Abdul Kader MASK, Wan Ahmad WA, Ong TK, Liew HB, Omar AF, Mahmood Zuhdi AS, Nuruddin AA, Schnorr B, Scheller B. Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon. JACC Cardiovasc Interv. 2019 Mar 25;12(6):558-566. doi: 10.1016/j.jcin.2018.11.040.